Clinical trial NCT05030870: Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients
Official title: Capnographic Monitoring Decrease the Incidence of Hypoxia of the Elderly Patients Undergoing Gastrointestinal Endoscopy Procedure: a Randomized Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Gastric Cancer
Gastric Polyp
Colon Polyp
Colon Cancer
Esophageal Cancer
Keywords: Capnographic Monitoring
Hypoxia
Gastrointestinal endoscopy
Elderly patients
Propofol
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Henan Provincial People's Hospital
name: Qilu Hospital of Shandong University
First posted: 2021-09-01
Enrollment: 1800
Sex: ALL
Minimum age (years): 65
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The incidence of hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary outcomes:
measure: The incidence of sub-clinical respiratory depression
timeFrame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
measure: The incidence of severe hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
measure: The incidence of capnography curve decreased by half or more than the baseline and even disappeared without hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
measure: The incidence of other adverse events
timeFrame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Other outcomes:
Locations:
city: Zhenzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Qingdao
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: Department of Anesthesiology Renji Hospital
name: Diansan Su, Dr.
role: PRINCIPAL_INVESTIGATOR
References: