Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients

NCT05030870 | Completed

• 1 other identifier: RenjiH-20201201
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Hypoxia; Gastric Cancer; Gastric Polyp; Colon Polyp; Colon Cancer; Esophageal Cancer

Keywords

Capnographic Monitoring; Hypoxia; Gastrointestinal endoscopy; Elderly patients; Propofol

Outcome Measures

Primary Outcomes (1)

• The incidence of hypoxia

  (75% ≤ SpO2 \< 90% for \<60 s)

  Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Secondary Outcomes (4)

• The incidence of sub-clinical respiratory depression

  Patients will be followed for the duration of hospital stay, an expected average about 2 hours

• The incidence of severe hypoxia

  Patients will be followed for the duration of hospital stay, an expected average about 2 hours

• The incidence of capnography curve decreased by half or more than the baseline and even disappeared without hypoxia

  Patients will be followed for the duration of hospital stay, an expected average about 2 hours

• The incidence of other adverse events

  Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Study Arms (2)

Capnographic monitoring group

EXPERIMENTAL

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.

Device: Capnography monitoring; Device: Standard monitoring

Standard monitoring group

ACTIVE COMPARATOR

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.

Device: Standard monitoring

Interventions

Capnography monitoring DEVICE

Standard monitoring and capnographic monitoring.

Capnographic monitoring group

Standard monitoring DEVICE

Standard monitoring but no capnographic monitoring

Capnographic monitoring group; Standard monitoring group

Eligibility Criteria

• Age: 65 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• ≤ Age \<80
• patients undergoing gastrointestinal endoscopes
• patients signed informed consent form
• ASA classification I-II

You may not qualify if:

• Coagulation disorders or a tendency of nose bleeding
• An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months
• Severe aortic stenosis or mitral stenosis
• Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months
• Acute myocardial infarction in the last 6 months
• Acute arrhythmia (including any tachycardia - or bradycardia) with the fluid of hemodynamics instability
• Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy)
• Pre-existing bradycardia (heart rate \< 50 / min), or hypoxia (SaO2\< 90 % )
• Need supplemental oxygen because of pre-existing diseases
• Emergency procedure or surgery
• Multiple trauma
• Upper respiratory tract infection
• Allergy to propofol or tape and adhesives

Sponsors & Collaborators

• RenJi Hospital: lead
• Henan Provincial People's Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator

Study Sites (3)

Henan Provincial People's Hospital

Zhenzhou, Henan, 450003, China

Location

Qilu Hospital of Shandong University

Qingdao, Shandong, 250012, China

Location

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (1)

• Lian Q, Chen S, Cheng X, Zhang J, Yu W, Zhou R, Su D. Capnographic monitoring reduces hypoxia incidence in older patients undergoing gastrointestinal endoscopy under propofol sedation: study protocol for a multicenter randomized controlled trial. Trials. 2023 Mar 15;24(1):192. doi: 10.1186/s13063-023-07208-0.

  PMID: 36918924 DERIVED

MeSH Terms

Conditions

Hypoxia; Stomach Neoplasms; Polyposis, Gastric; Colonic Polyps; Colonic Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases

Study Officials

• Diansan Su, Dr.

  Department of Anesthesiology Renji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of the Department of Anesthesiology

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: September 1, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: January 1, 2023
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

CN (3)