Symptoms and General Pathology

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Postoperative Complications

Pulmonary Atelectasis

Facies

Hypoxia

Signs and Symptoms, Respiratory

Lung Diseases

Respiratory Tract Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Oxygen delivered by high flow nasal cannula (HFNC) 60 l/min

high flow nasal cannulae delivering 60 l/min

HFNC - Airvo 2

Oxygen

Luciano Frassanito, MD

The primary aim of this study is to assess the efficacy of post-operatory HFNC in reducing the incidence of hypoxemia after gynecological oncology surgery, compared to the standard application of O2 through a Venturi mask; The secondary objectives are to investigate the occurrence and entity of lung atelectasis, to evaluate diaphragmatic function and respiratory discomfort, and to evaluate the incidence of respiratory complications after seven days in the two groups.

Patients will be randomized into two groups: HFNC and Control. The patients will be studied with preoperative lung and diaphragmatic ultrasound. Standard general anesthesia will be administered in the two groups. Ultrasound will be performed at arrival in the recovery room (RR) and before discharge from the RR. In the HFNC group, high-flow O2 will be administered; in the control group standard O2 therapy with Venturi mask will be administered.

Arterial blood gas analysis upon arrival in the RR and after two hours of O2 therapy in both groups will be checked.

The incidence of post-operative respiratory complications will be monitored in the seven days following surgery.

Post-operative hypoxemia presents in 10-50% of patients undergoing surgery, and it is associated to unfavourable prognosis. Anesthesia-induced paralysis, the use of high oxygen concentrations (O2) and inadequate level of positive end expiratory pressure (PEEP), capnoperitoneum, Trendelenburg position, prolonged duration of surgery, contribute to pulmonary atelectasis, which are the principal cause of postoperative hypoxemia.

The use of high flow nasal cannulas (HFNC) has been recently studied in the treatment of hypoxemic patients in intensive care unit and in the immediate post-operatory period after abdominal and cardio-thoracic surgery. The role of post-operative HFNC in patients undergoing major gynecological oncology surgery has yet to be assessed.

Lung ultrasound is a safe and accurate bedside tool that allows to investigate pulmonary aeration and atelectasis developement. Diaphragmatic ultrasound is a recent bedside technique useful to assess diaphragm performance.

The principal aim of this study is to assess the efficacy of post-operatory HFNC in reducing the incidence of hypoxemia after gynecological oncology surgery, compared to the standard application of O2 through the Venturi mask. The secondary objectives are to investigate the occurrence and entity of lung atelectasis, to evaluate diaphragmatic function and respiratory discomfort, and to evaluate the incidence of respiratory complications after seven days in the two groups.

Study Design and Length:

this is an interventional, prospective, randomized (with standard and experimental groups) monocentric study. The study will be 12-months in length and it will be carried out in the operating rooms of the 6° floor of the IRCCS Fondazione Policlinico Universitario Agostino Gemelli.

Materials and Methods:

The patients eligible for recruitment will be randomized with a computerized system and will be included in wither the HFNC or C group.

Upon arrival in the operating room lung and diaphragmatic ultrasound will be performed according to the international recommendations of Point of Care. A SonoSite ultrasound with Convex probe, with abdominal presetting and depth set at 9-12 cm, will be used. The ultrasound probe will be positioned between the ribs with the marker facing cranially and position perpendicular to the thoracic cage, oriented along the longitudinal axis of the patient. The image generated this way will show the superior rib on the left the screen and the inferior rib on the right of the screen, both represented by acoustic shadowing. The pleural line will appear between the costal shadows as a slightly curved and eco-reflective line. In the healthy lung, it is possible to appreciate pleural "sliding" generated by the movements of the visceral pleura against the parietal pleura during each breath. This movement will be more pronounced along the lung bases and more blurred at the apices. Horizontal lines at regular intervals below the pleura that may be appreciated represent reverberation artefacts that are defined as "A lines." On the other hand, the "B lines," that are also know as "comets" are artefacts produced by the interface of the normally aerated lung parenchyma with higher-density areas. These will present as vertical lines that start from the pleura and develop up to the end of the image, covering the A lines and consensual to respiratory movements. Twelve images will be acquired, one for each thoracic section obtained through the following method: for each hemithorax, anterior, posterior and lateral portions will be recognized relative to the anterior and posterior axillary lines, respectively. Each section will be further subdivided into superior and inferior by the intermammillary line. The posterior images will be acquired with the patient lying in lateral decubitus. A score ranging from 0 to 3 according to Monastesse criteria will be assigned to each of the 12 quadrants. For each quadrant the worst (higher) score will be considered, indicating more severe aeration loss. Individual scores will be added to calculate the cumulative lung ultrasound (LUS) score (0-36).

0: Normal aeration = visualization of pleural sliding and A lines parallel to the pleura with \< 3B lines.1: Mild loss of aeration = ≥3 B lines or multiple subpleural consolidations separated by normal pleura. 2: Moderate loss of aeration = multiple and coalescent B lines of multiple subpleural consolidations separated by thickened or irregular pleura. 3. Severe loss of aeration = parenchymal consolidations or multiple subpleural consolidations greater than 1×2 cm in dimensions.

For diaphragmatic ultrasound a linear high frequency probe will be used. The operator identifies the caudal border of the costophrenic sinus as the zone of transition from the artefactual representation of the aerated lung to the visualization of the diaphragm and liver on the right side. The diaphragm will be identified by the two hyperechoic lines of pleural and peritoneal membranes. In M-mode, both the respiratory phases are represented in the same frame. The diaphragm thickness at end-inspiration (TEI), at end-expiration (TEE) will be measured and the thickening fraction (TF) will be calculated using the formula TF = (TEI - TEE)/TEE.

The clinical and respiratory parameters from the patients' medical records will also be reported.

A venous access will be placed, according to normal clinical practice. The use of neuro-axial blocks (spinal or epidural), as well as the placement of a central venous catheter, arterial catheter, a second large bore venous access, will be left to the judgement of the anesthesist in charge of the patient. The induction of general anesthesia will follow a preoxygenation with inspired oxygen fraction (FiO2) =1 for three minutes. The intraoperative mechanical ventilation settings will be standardized, with tidal volume set at 8ml/kg of predicted body weight, PEEP 5 cmH2O, respiratory frequency set to maintain PaCO2 within physiological limits, I:E ratio of 1:2. In case of intraoperative arterial desaturation (SpO2 \< 95%) different techniques will be adopted in the following order: recruitment maneuvers, increase in PEEP, and increase in FiO2.

After awakening from general anesthesia the patients will be moved to the RR where standard multiparametric monitoring will be started, an arterial blood sample will be drawn for blood gas analysis and a second lung and diaphragmatic ultrasound will be performed following the same criteria already listed above. Respiratory rate and a Visual Analogue Scale (VAS) for discomfort and dyspnoea will be filled out.

At this point, the patients selected for the C group will undergo conventional O2-therapy Venturi mask. In the patients belonging to the HFNC group, high flow O2 (60 lt/min) will be administered through the use of nasal cannulas with the Opti-Flow circuit. In both groups the starting FiO2 will be 21% and will be increased of necessary to obtain a SpO2\>92. After two hours of therapy a new arterial blood gas analysis, a third lung-diaphragmatic ultrasound, respiratory rate, a Visual Analogue Scale (VAS) for discomfort and dyspnoea will be noted, before the patients are transferred to the ward.

On the seventh day after surgery all of the eventual episodes that may be classified as postoperative pulmonary complications (PPC) will be recorded (hypoxemia, pleural effusion, lung edema, pulmonary embolism, pneumonia, acute respiratory distress syndrome (ARDS), bronchospasm, lung aspiration, pneumothorax).

Population of the study

Statistical Considerations Sample Dimension The literature indicates that roughly 50% of patients, treated with O2 therapy, develops hypoxemia one hour from extubation. Assuming that in the experimental branch (arm) that percentage is 15%, considering a strength of 90% and an alpha =0.05, a sample size of 66 patients will be obtained (33 per branch), at which a 20% of dropout will be added to reach the final sample size of N = 80 patients (40 per arm).

Data Analysis The sample will be described in its clinical and demographic characteristics through the techniques of descriptive statistics. In particular, quantitative variables will be represented though the following measurements: minimum, maximus, range, mean and standard deviation, or median and interquartile range. Qualitative variables will be represented through absolute frequencies and percentages. The normality of continuous variables will be validated through the Kolmogorov-Smirnov test. The primary aim will be reached comparing the two proportions through the Chi-squared test, while the change in Pa/FiO2 at the different time points, among the two groups of patients will be assessed by the Student's t-test. The secondary objective of comparing the incidence of PPC after seven days in the two branches will be also attained through the Chi-squared test. The p-value\<0.05 indicates statistical significance. All of the statistical analysis will be done with SPSS 25.

Interventional, prospective, randomized (with standard and experimental groups) monocentric study

poStoperative Anesthesia Care: Facial Mask vs Hfnc and Thoracic Ultrasound for Reduction of Atelectasis Incidence

Effects of the Application of a High-flow System Nasal Cannulas (Opti-Flow) Post General Anesthesia Versus Conventional Oxygen Therapy for Post-operative Hypoxemia After Gynecological Oncology Surgery

Change in arterial Pa/FiO2 (in mmHg) in the two groups

Change in cumulative Lung ultrasound score for pulmonary aeration (from 0 to 36) in the two groups.

Change in diaphragmatic ultrasound thickening at end inspiration (Tei) minus diaphragmatic thickening at end expiration (Tee) divided for diaphragmatic thickening at end expiration

Change in arterial CO2 partial pressure (PaCO2, mmHg), in respiratory rate (number per minute), in dyspnoea index (visual analogue scale, from 1- no dyspnoea to 10- intense respiratory efforts), in comfort index (as visual analogue scale, from 1- no discomfort to 10- severe discomfort).

Incidence of hypoxemia, pleural effusion, lung edema, pulmonary embolism, pneumonia, ARDS, bronchospasm, lung aspiration, pneumothorax

Post-hoc subanalysis of arterial Pa/FiO2 in hypoxemic patients (paO2\<60 mmHg at arrival in the recovery room) in the two groups

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Neoplasms

Nervous System Diseases

Immune System Diseases

Infections

Rare Diseases

Syndrome

Myasthenia Gravis

Guillain-Barre Syndrome

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Nervous System Neoplasms

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Neurodegenerative Diseases

Neuromuscular Junction Diseases

Neuromuscular Diseases

Polyradiculoneuropathy

Demyelinating Diseases

Polyneuropathies

Peripheral Nervous System Diseases

Communicable Diseases

Post-Infectious Disorders

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Respiratory System Agents

Patients will be examined in the supine position. diaphragmatic thickness will is measured on both sides during a deep breath in inspiration and during expiration.

Patients hospitalized with neurological disorders without affection of the respiratory system.

diaphragmatic thickness will be measured on both sides during a deep breath in inspiration and during expiration.

diaphragmatic ultrasound

Aya M Zhran

participants will be allocated into three groups, acute neuropathy (Guillain Barre Syndrome) group, neuromuscular junction disorder(myasthenia gravis ) group, and control group(people with neurological disorders not affecting the respiratory system.Ultrasonography is done on the diaphragm. The index test (ultrasound imaging of the diaphragm) is used. A high-resolution portable ultrasound machine is used, with a 7- to 13-MHz linear array transducer. Patients will be examined in the supine position. diaphragmatic thickness will is measured on both sides during a deep breath in inspiration and during expiration. objectives: primary outcome: to compare diaphragm thickness between the three examined groups. Secondary outcome: correlation between clinical scores and reference US values of diaphragm

after IRB (institutional research board ) approval, of the faculty of medicine, Mansoura University, Egypt, written informed consent from all participants will be taken. participants will be allocated into three groups, acute neuropathy (Guillain Barre Syndrome) group, neuromuscular junction disorder(myasthenia gravis ) group, and control group(people with neurological disorders not affecting the respiratory system. inclusion group: age more than 18, both sexes. exclusion criteria: cardiopulmonary disease, chest trauma, diaphragmatic injury, body mass index more than 30. Any participant who shows respiratory dysfunction on doing arterial blood gases and pulmonary function tests will not be enrolled in the study. methods: Ultrasonography is done on the diaphragm. The index test (ultrasound imaging of the diaphragm) is used. A high-resolution portable ultrasound machine is used, with a 7- to 13-MHz linear array transducer. Patients will be examined in the supine position. diaphragmatic thickness will is measured on both sides during a deep breath in inspiration and during expiration. objectives: primary outcome: to compare diaphragm thickness between the three examined groups. Secondary outcome: correlation between clinical scores and reference US values of diaphragm

Patients will be examined in the supine position. diaphragmatic thickness will is measured on both sides during a deep breath in inspiration and during expiration in the 3 groups: (1) Gillian-Barre syndrome; (2) Myasthenia Gravis; (3) control

Diaphragm Thickness by Ultrasonography in Neurological Disorders

Assessment of Diaphragm Thickness by Ultrasonography in Guillain Barre Syndrome and Myasthenia Gravis

Anonymous patients' data will be available with the PI or corresponding Author on reasonable request according to local IRB regulations

score of disability 1-5, "Hughes RA, Newsom-Davis JM, Perkin GD, Pierce JM.Controlled trial prednisolone in acute polyneuropathy.Lancet. 1978;2:750-3"

Mansoura University

Pleural Effusion

Lung Neoplasms

Dyspnea

Pleural Effusion, Malignant

Pleural Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

patients with lung neoplasms and malignant pleural effusions who need a diagnostic or therapeutic thoracocentesis

diaphragmatic ultrasound measure

Mickaël OHANA

Malignant pleural effusions cause breathlessness and impairs quality of life. Thoracocentesis is frequently used to relieve breathlessness.

The severity of breathlessness correlates poorly with the size of the effusion. Symptom reduction from fluid drainage varies between patients. No predictors exist to identify which patients benefits more of pleural effusion. One study suggests that a inverted hemidiaphramatic (inverted shape) is associated with a greater dyspnea improvement. Others parameters of diaphragmatic motion have not been studied till now.

This study aims to evaluate the feasability of diaphragmatic ultrasound evaluation (shape by B-mode, quiet, deep inspiratory motion and sniff diaphragm motion by TM-mode) before and after pleural drainage.

Primary end point aims to evaluate the feasability of deep breath inspiratory excursion in ipsilateral side of thoracocentesis by anterior subcostal approach in the mid-clavicular line in the right in patients with malignant pleural effusions. The liver or spleen was identified as a window for each hemidiaphragm.

Secondary end points aim to evaluate

* the feasability of quiet breath inspiratory motion ,
* the feasability of sniff diaphragm motion
* the feasability of deep breath inspiratory motion by posterior method
* the comparaison of feasibility with different types of breathing and or anterior or posterior approach for ultrasound
* the feasability of the shape by B-mode.
* the correlation between the change of the shape of ipsilateral diaphragm and the evolution of dyspnea, before and after thoracocentesis.
* the correlation between the volume of pleural effusion evacuated and the evolution of dyspnea, before and after thoracocentesis.
* the comparaison of the changing of dyspnea in patients with noticed paradoxal movement of diaphragm before thoracocentesis and patients with persistent paradoxal/or non persistant paradoxal movement of ipsilateral hémidiaphragm.
* the correlation between the feasability of diaphragmatic ultrasound motion measurments evaluation and the body mass index.
* the comparaison between the different diaphragmatic ultrsound times for anterior or posterior approach.

Quantitative Diaphragmatic Ultrasound Evaluation in Pleural Effusions : A Feasability Study

Quantitative Diaphragmatic Ultrasound Evaluation in Pleural Effusions

Rate of patients with a feasible measure of diaphragmatic amplitude in wide breathing (RA), on the side homolateral to the pleural puncture, by the anterior route before and after pleural puncture.

Rate of patients with a feasible measure of diaphragmatic amplitude in spontaneous breathing (RS), on the side homolateral to the pleural puncture, by the anterior route before and after pleural puncture.

University Hospital, Strasbourg, France

All patients will receive pre-operative pleural-based ultrasound during their initial consultation.

thoracic ultrasound

Before proceeding to pleural aspiration, a radiography of the chest will be performed in order to ascertain the presence of a pleural effusion.

pleural aspiration

Moishe Liberman, MD, PhD

Lung cancer remains the leading cause of mortality from malignant diseases in both men and women worldwide. Accurate diagnosis, staging and therapeutic targeting of lung cancer and other pulmonary pathology are vital with regards to providing patients with expedient and accurate treatment and treatment plans. The pre-operative evaluation and consultation in patients who are to undergo operative staging or resection for lung cancer is multidimensional and involves detailed history taking, physical examination and review of imaging studies. Two important elements of both staging and pre-operative evaluation include the evaluation of: (1) the pleural space for malignant pleural effusion and (2) the diaphragm for appropriate movement. At this point in time, the pleural space evaluation is being performed using CT scan which does not allow the acquisition of real-time cytological material from pleural effusions due to the fact that the CT scans are done in a diagnostic setting. Diaphragmatic movement/excursion is not currently being assessed pre-operatively and its impact on staging and post-operative pulmonary function is unknown.

Malignant pleural effusion is recognized as a poor prognosticator in non-small cell lung cancer patients and has recently been upgraded from a T4 to an M1a status in the new edition of the AJCC NSCLC Staging System (7th Edition). The appreciation of the poor prognosis related to malignant effusion has upgraded the stage from a Stage IIIb to a stage IV. Recognizing the stage early allows for more precise prognostication of disease and can lead to precision and streamlining of treatment plans for thoracic surgeons and oncologists.

Hypotheses:

1. Pleural ultrasonography with evaluation, quantification and aspiration of pleural effusion allows for improved pre-operative staging and alters decision-making patterns for lung cancer patients.
2. Pleural ultrasonography with evaluation of appropriate diaphragmatic respiratory movement can predict post-operative complications in patient undergoing lung cancer surgery.

Objectives:

The goals of this project within the program are to:

1. Evaluate the improvement in pre-operative staging with the addition of pre-operative pleural ultrasonography for malignant pleural effusion.
2. Evaluate the ability of pre-operative diaphragmatic ultrasound to predict post-operative morbidity following pulmonary surgery.

Methodology:

This study will consist of a prospective evaluation of surgeon-performed pleural and diaphragmatic ultrasound in the pre-operative evaluation of lung cancer patients. All patients being seen in the thoracic surgery pre-operative clinic with the new or presumed diagnosis of lung cancer will be approached for prospective enrolment into the study. Consented patients will undergo standard history and physical examination by the treating thoracic surgeon. During or after the physical examination, PULC will be performed by the study investigators.

Measurements will include: (1) bilateral diaphragmatic excursion during sniffing, (2) pleural fluid evaluation in bilateral costophrenic sulci. Should pleural fluid be found on the ipsilateral side to the mass (tumor), the fluid will be aspirated under sterile conditions in the clinic and sent for cytology analysis. US evaluation will be performed in the upright, supine and decubitus position.

Results will be analyzed using parametric methodology in order to ascertain the additional information gained and the change in staging (upstaging) with the addition of PULC to standard history and physical examination during the initial evaluation of thoracic surgical patients.

The study will enrol 50 patients. Recruitment will occur at the thoracic outpatient surgical clinic at the CHUM. Enrolment is expected at a level of five patients per week and therefore the study recruitment is expected to take 2.5 months.

Impact:

The potential impact of a positive trial will change the way clinicians evaluate, stage and risk stratify patients who are to undergo operative interventions for lung cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
poStoperative Anesthesia Care: Facial Mask vs Hfnc and Thoracic Ultrasound for Reduction of Atelectasis Incidence	NCT04566419	Pulmonary Atele... Postoperative C... Gynecologic Can... Anesthesia Hypoxemia	HFNC - Airvo 2 Oxygen	18 Years -	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Diaphragm Thickness by Ultrasonography in Neurological Disorders	NCT05324176	Guillain-Barre ... Myasthenia Grav...	diaphragmatic u...	18 Years -	Mansoura University
Quantitative Diaphragmatic Ultrasound Evaluation in Pleural Effusions : A Feasability Study	NCT04264325	Malignant Pleur... Lung Neoplasms	diaphragmatic u...	18 Years -	University Hospital, Strasbourg, France
Pleural Ultrasonography in Lung Cancer	NCT01141946	Lung Cancer	thoracic ultras... pleural aspirat...	18 Years -	Centre hospitalier de l'Université de Montréal (CHUM)
Quantitative Diaphragmatic Ultrasound Evaluation in Pleural Effusions : A Feasability Study	NCT04264325	Malignant Pleur... Lung Neoplasms	diaphragmatic u...	18 Years -	University Hospital, Strasbourg, France

Spots Global Cancer Trial Database for diaphragmatic ultrasound