Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Multiple Pulmonary Nodules

Solitary Pulmonary Nodule

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen.

After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide.

During one-lung ventilation with an open chest, the non-ventilated lung collapses initially due to the inherent elastic recoil properties of the lung. Once passive venting has ceased, further collapse will then be wholly dependent on ongoing gaseous uptake and absorption atelectasis. Improved inflation-deflation method is currently the most widely used method in clinical practice. After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. After the operative lungs is completely expanded, perform pure oxygen mechanical single lung ventilation for the healthy lung, waiting for clear presentation of the plane between the targeted segment and the other segments.

100% oxygen

During one-lung ventilation with an open chest, the non-ventilated lung collapses initially due to the inherent elastic recoil properties of the lung. Once passive venting has ceased, further collapse will then be wholly dependent on ongoing gaseous uptake and absorption atelectasis. The solubility coefficient for carbon dioxide is 0.57. The rapid diffusion properties of carbon dioxide would be expected to speed lung collapse and so facilitate surgery. After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide. After the operative lungs is completely expanded, perform pure oxygen mechanical single lung ventilation for the healthy lung, waiting for clear presentation of the plane between the targeted segment and the other segments.

Carbon dioxide

With the increasing acceptance of routine computed tomography (CT) screenings, early-stage lung cancer detection is becoming more frequent. For ground glass opacity predominant early-stage lung cancer, segmentectomy can get the same oncological benefits as lobectomy. In addition, lung nodules that are highly suspected to be metastases can also be performed by segmentectomy to preserve more lung function. During the surgery, the rapid and precise identification of the intersegmental plane is one of the challenges. The improved inflation-deflation method is currently the most widely used method in clinical practice. According to the dispersion coefficient of the gas, the rapid diffusion properties of carbon dioxide would be expected to speed lung collapse and so facilitate surgery. The purpose of this study was to investigate the feasibility and safety of carbon dioxide on the appearance time of satisfactory and ideal planes during segmentectomy.

This study was approved by the ethics committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. This randomized parallel group trial enrolled patients scheduled to receive thoracoscopic anatomic segmentectomy at Tongji Hospital. General anesthesia with double lumen endotracheal tube was administered to the patients. With the guidance of preoperative three-dimensional computed tomography bronchography and angiography, the targeted segment structures could be precisely dissected, and then intersegmental demarcation was confirmed by the modified inflation-deflation method in this study. In group A (100% oxygen), after dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. In group B (Carbon dioxide), after the targeted segment structures were successfully dissected, the collapsed operative lung was completely re-expanded with carbon dioxide. The purpose of this study was to investigate the feasibility and safety of carbon dioxide on the appearance time of satisfactory and ideal planes during segmentectomy. The starting time point of the intersegmental plane was when the whole lungs had completely re-expanded. The end point was when the preserved segment was fully deflated, and a boundary had formed between the targeted segment and the reserved lung.

Application of Carbon Dioxide for Identifying the Intersegmental Plane in Thoracoscopic Segmentectomy

Application of Carbon Dioxide for Identifying the Intersegmental Plane in Thoracoscopic Segmentectomy: A Randomized Controlled Study

Duration of hospitalization after surgery.

Measured using the Quality of Recovery 40 (QoR-40) Score and asking patients to complete the questions 24 hours before operation, 48 hours after operation and 1 week after operation.

The starting time point of the intersegmental plane was when the whole lungs had completely re-expanded. The end point was when the preserved segment was fully deflated, and a boundary had formed between the targeted segment and the reserved lung.

Tongji Hospital

Professor

After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen.

100% oxygen: During one-lung ventilation with an open chest, the non-ventilated lung collapses initially due to the inherent elastic recoil properties of the lung. Once passive venting has ceased, further collapse will then be wholly dependent on ongoing gaseous uptake and absorption atelectasis. Improved inflation-deflation method is currently the most widely used method in clinical practice. After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. After the operative lungs is completely expanded, perform pure oxygen mechanical single lung ventilation for the healthy lung, waiting for clear presentation of the plane between the targeted segment and the other segments.

Group A: 100% Oxygen

After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide.

Carbon dioxide: During one-lung ventilation with an open chest, the non-ventilated lung collapses initially due to the inherent elastic recoil properties of the lung. Once passive venting has ceased, further collapse will then be wholly dependent on ongoing gaseous uptake and absorption atelectasis. The solubility coefficient for carbon dioxide is 0.57. The rapid diffusion properties of carbon dioxide would be expected to speed lung collapse and so facilitate surgery. After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide. After the operative lungs is completely expanded, perform pure oxygen mechanical single lung ventilation for the healthy lung, waiting for clear presentation of the plane between the targeted segment and the other segments.

Group B: Carbon Dioxide

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

China

Region of Enrollment

body mass index (BMI)

Dr. Wei Ping

The Intersegmental Border Appearance Time During the Surgery.

The Arterial Blood Gas Results During Perioperative Period.

The Incidence of Postoperative Complications.

The Length of Hospital Stays.

Quality of Recovery.

Overall Study

Nervous System Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Delirium

Confusion

Neurobehavioral Manifestations

Neurologic Manifestations

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Central Nervous System Depressants

All Drugs and Chemicals

Antipyretics

Analgesics

Anti-Inflammatory Agents

Antirheumatic Agents

Anesthetics

Acetaminophen

Ibuprofen

Analgesics, Non-Narcotic

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Patients in the Maxigesic group will be administered a total of 5 doses of the drug (20mg/kg, maximum dose per serving: 1g) every 6 h from immediately after anesthetic induction.

Acetaminophen and Ibuprofen

Patients in the control group will be administered equal amounts of normal saline at the same time points.

Normal saline

Heezoo KIM, MD, PhD

Hye Bin KIM, MD, PhD

Hye Bin Kim, MD, PhD

Heezoo Kim, MD, PhD

The primary aim of this interventional study is to investigate the impact of perioperative administration of Maxigesic (combination of acetaminophen and ibuprofen) on delirium after minimally invasive lung surgery in elderly patients. The Maxigesic group receives a total of 5 doses of Maxigesic (20mg/kg, maximum dose per serving: 1g) every 6 h from immediately after anesthesia induction. The control group receives the same volume of normal saline. Researchers compare the incidence and severity of postoperative delirium for 5 days after surgery.

Impact of Maxigesic on Delirium After Minimally Invasive Lung Surgery in Elderly Patients

The Impact of Intravenous Administration of Perioperative Acetaminophen and Ibuprofen Combination (Maxigesic®) on Postoperative Delirium in Elderly Patients Undergoing Minimally Invasive Lung Segmentectomy or Lobectomy

The investigators have no plans yet to share individual participant data (IPD) with other researchers.

Confusion assessment method(CAM)/Confusion Assessment Method for the ICU (CAM-ICU) or delirium record on electrical medical record(EMR) will be used for the evaluation of POD.

CAM-S(severity) will be utilized to assess the severity of POD. (\*CAM-S is measured on 0-7 (short form) and 0-19 (long form) scale, and the higher the score, the greater the POD severity.)

CAM/CAM-ICU or delirium record on EMR will be used to estimate the duration of POD.

Mini-mental state examination(MMSE) will be used to evaluate the participants' preoperative cognition. (\*MMSE is measured on 0-30 scale, and the lower the score, the more cognitively impaired the patient is.)

Montreal cognitive assessment(MoCA) will be used to evaluate the participants' preoperative cognition. (\*MoCA is measured on 0-30 scale, and the lower the score, the more cognitively impaired the patient is.)

Clinical frailty scale(CFS) will be utilized to assess the preoperative frailty (\*CFS is used to determine comprehensive geriatric assessment. It is measured on 1-9 scale, and the higher the scale, the more frail the patient is.)

Numerical rating scale (NRS) or Visual analogue scale (VAS) will be used to determine the postoperative pain severity (\*NRS and VAS are measured on a 0-10 scale, and the higher the score, the more severe the patient's pain. If the patient can verbalize their pain, use the NRS; otherwise, use the VAS to assess pain).

Opioid consumption is measured by converting them into morphine equivalents.

Nausea is measured by scoring on a scale of 0-10. The higher the score, the more severe the symptom. Whether the patients vomit or not is observed and recorded.

Determine how many days the participant stays in the ICU.

Determine how many days the participant stays in the hospital.

Investigate all kinds of complications that occur after surgery.

Investigate complications suspected to be side effects caused by the study drug.

Kyongbo Pharmaceutical Co.,Ltd

Korea University Guro Hospital

Before minimally invasive lung segmentectomy, preoperative chest CT scans are processed and evaluated with multi-plane (2D) reconstructions, according to the usual center protocol.

Before minimally invasive lung segmentectomy, preoperative chest CT scans are processed and evaluated with volume rendering (3D) reconstructions.

Before performing the surgery, patient performs a chest CT scan with contrast medium and standard two-dimensional (2D) reconstructions are performed to study the lesion, the anatomy of the bronchi and the pulmonary venous and arterial vessels.

CT scans 2D Reconstruction

Before performing the surgery, patient performs a chest CT scan with contrast medium and standard two-dimensional (2D) reconstructions plus a 3D reconstruction are performed to study the lesion, the anatomy of the bronchi and the pulmonary venous and arterial vessels.

CT scans 2D plus 3D Reconstruction

ZARACA Zaraca

Marco Damiano Pipitone

ZARACA FRANCESCO

With this project we want to study the effectiveness of 3D reconstruction of preoperative CT to reduce operating times, blood loss and conversions after segmentectomy performed in thoracoscopy / robotics.

Pulmonary segmentectomy is the surgery of first choice in malignant lung tumors with a diameter \<2 cm in diameter. Patients who are candidates for this type of treatment perform usually a preoperative CT scan with two-dimensional reconstructions (2D: axial, coronary and sagittal). Today it is possible to perform a preoperative three-dimensional reconstruction (3D: volume rendering) of the vessels and bronchi using special software.

Objectives of the study is to analyze, in these patients, the benefits of 3D reconstruction of vessels and bronchi compared to 2D reconstruction, analyzing intra- and post-operative data.The study aims to randomize 288 patients over 36 months.

Study design: Prospective, randomized, controlled study. In 50% of patients the preoperative study of anatomical structures will be performed with the standard 2D method, in the remaining 50% with a 2D and 3D reconstruction. The assignment will take place through access to an online feature on the study website.

Evaluations and statistical methods The statistical analysis will be carried out using parametric and nonparametric descriptive, inferential statistical methods, while the main outcome will be carried out using the analysis of variance (ANOVA) and covariance (ANCOVA) techniques.

Ethical aspects. The study will be conducted in accordance with applicable current legislation. Approval by all relevant ethics committees will be required. Each patient will provide a written consent to participate in the study, after being properly informed.

A prospective multicenter randomized study

Prospective rAndomized sTudy efficaCy tHree-dimensional rEconstructions Segmentectomy

Prospective Randomized Study on the Efficacy of Three-dimensional Reconstructions of Bronchial and Vascular Structures on Preoperative Chest CT Scan in Patients Who Are Candidates for Pulmonary Segmentectomy Surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Application of Carbon Dioxide for Identifying the Intersegmental Plane in Thoracoscopic Segmentectomy	NCT05350137	Lung Cancer Pulmonary Nodul... Segmentectomy Pulmonary Nodul...	100% oxygen Carbon dioxide	18 Years - 80 Years	Tongji Hospital
Impact of Maxigesic on Delirium After Minimally Invasive Lung Surgery in Elderly Patients	NCT05834569	Delirium Aged Lung Neoplasms Robotic Surgica... Thoracic Surger...	Acetaminophen a... Normal saline	65 Years -	Korea University Guro Hospital
Prospective rAndomized sTudy efficaCy tHree-dimensional rEconstructions Segmentectomy	NCT05716815	Lung Cancer Lung; Node	CT scans 2D Rec... CT scans 2D plu...	18 Years -	Ospedale Centrale Bolzano

Spots Global Cancer Trial Database for lung segmentectomy