Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Esophageal Neoplasms

Hypoxia

Colonic Polyps

Polyps

Pathological Conditions, Anatomical

Signs and Symptoms, Respiratory

Stomach Cancer

Esophageal Cancer

Central Nervous System Depressants

All Drugs and Chemicals

Propofol

In this group, in addition to the standard monitoring including observation, pulse oxygen saturation, non-invasive blood pressure, electrocardiogram in selected patients, the capnographic is also monitored. The capnographic data of the patients are available for additional noninvasive assessment of ventilation.

In this group, standard monitoring including observation, pulse oxygen saturation, non-invasive blood pressure, electrocardiogram in selected patients. Capnographic data are not visible by closing the CO2 sampling line till the endoscopy end.

Standard monitoring and capnographic monitoring.

Capnography monitoring

Standard monitoring but no capnographic monitoring

Standard monitoring

Diansan Su, Dr.

Hypoxia is the most common adverse event in gastrointestinal endoscopes sedated with propofol and sufentanil, especially in elderly people. The aim of this randomized study was to determine whether intervention based on additional capnographic monitoring reduces the incidence of hypoxia in gastrointestinal endoscopes procedures for elderly patients.

Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients

Capnographic Monitoring Decrease the Incidence of Hypoxia of the Elderly Patients Undergoing Gastrointestinal Endoscopy Procedure: a Randomized Multicenter Clinical Trial

(SpO2 \< 75% or 75% ≤ SpO2 \< 90% for \>/=60 s)

capnography curve decreased by half or more than the baseline and even disappeared, SpO2 \>90%

Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force

Henan Provincial People's Hospital

Qilu Hospital of Shandong University

RenJi Hospital

Vice Chair of the Department of Anesthesiology

Immunomodulating Agents

Intensive phone monitoring of drug adverse events

Standard monitoring of drug adverse events

periodic and planned monitoring nurse intervention with phone call

Intensive monitoring

standard monitoring of adverse event reaction

Paolo Bossi, MD

Andrea Antonuzzo, MD

The lacking adherence to guidelines on prevention and treatment of different chemotherapy, targeted therapy, and immunotherapy induced toxicities is the reason why there are a potential incidence and duration increase of adverse events. It is clear the need of a collateral effect early recognition for an adequate clinical management and for limiting their intensity and duration.

There is the need for a multicentre randomized clinical study in specific therapeutical settings (chemotherapy, target therapy, immunotherapy) assessing the impact of planned and ongoing patients' monitoring by nurses.

The NICSO study foresees patient enrolment that is in adjuvant chemotherapy for breast cancer, colon, and lung; that is in chemotherapy or immunotherapy or with targeted therapy. Moreover, this working assesses toxicity differences (but also of QoL, number of PS access or non-planned medical examinations, number of hospitalization and number of recovery days) in patients that carried out a toxicity prevention and cure standard therapy in comparison with the standard assessment to which is added a periodic nursing phone intervention.

The lacking adherence to guidelines on prevention and treatment of different chemotherapy, targeted therapy, and immunotherapy induced toxicities is the reason why there are a potential incidence and duration increase of adverse events. It is clear the need of a collateral effect early recognition for an adequate clinical management and for limiting their intensity and duration.

A better toxicity management can have a positive impact on a correct treatments dose-intensity. Scientific community debate on toxicity assessment ways and means is still open. The most debated questions concern:

* Physician and/or patient reporting adverse events;
* Nurse role in the adverse events assessment;
* How much assessment methods (assessment frequency, who's involved in adverse events monitoring) means for:

  * Time spent with toxicity and intensity reduction;
  * Treatment adherence. Some literature evidence is avaiable and support the need of intensive monitoring of patients in terms of adverse events. However, there is the need for a multicentre randomized clinical study in specific therapeutical settings (chemotherapy, target therapy, immunotherapy) assessing the impact of planned and ongoing patients' monitoring by nurses.

This is a multi-centric, randomized, open comparative study design, between a planned and consecutive monitoring nurse intervention in addition to the chemotherapy toxicity prevention and cure standard therapy package insert (chemotherapy, target therapy, immunotherapy), and the only use of the cancer therapy toxicity prevention and cure standard therapy package insert (chemotherapy, target therapy, immunotherapy).

The study involves All the patients with a solid tumor on treatment with adjuvant chemotherapy or receiving target therapy or immunotherapy for the first time in their cancer history.

This study design will last 24 months. Patient recruitment will last 18 months from the beginning of the study. The study period will be 4 months for the group on treatment with immunotherapy and target therapy and at least 6 months for the group on treatment with adjuvant chemotherapy. The study could be interrupted when there is a therapy withdrawal because of cancer progression, severe toxicity or for the informed consent for withdrawal, or because of death. If there is a temporary interruption or a treatment withdrawal period, patients still are in under monitoring, according to their group. The study will end with the end of the planned period monitoring, which is the last call to the enlisted patients.

Two comparison groups: an intervention group (intensive phone monitoring of adverse event reactions) compared with a placebo group (standard monitoring)

NICSO National Study: Physician - Nurse Monitoring Project About Oncological Adverse Events

Changes intreatment dose intensity (Dose intensity)

Assessment of the number of days that have passed with at least a toxicity grade \>= 3. The assessed toxicities have been chosen for their clinical relevance and for their higher danger to reduce patients' treatment adherence, invalidating therapy benefits.

incidence and duration of grade 1 and 2 toxicity

number of ER admissions and number of non-planned medical examinations

number of hospitalization and its duration because of treatment toxicity

administration of validated questionnaires and evaluation of patients'quality of life

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients	NCT05030870	Hypoxia Gastric Cancer Gastric Polyp Colon Polyp Colon Cancer Esophageal Canc...	Capnography mon... Standard monito...	65 Years - 79 Years	RenJi Hospital
Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients	NCT05030870	Hypoxia Gastric Cancer Gastric Polyp Colon Polyp Colon Cancer Esophageal Canc...	Capnography mon... Standard monito...	65 Years - 79 Years	RenJi Hospital
NICSO National Study: Physician - Nurse Monitoring Project About Oncological Adverse Events	NCT04726020	Cancer	Intensive monit... Standard monito...	18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Spots Global Cancer Trial Database for standard monitoring