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HypoxiaCapnoGINCT05030870

Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients

A study testing Capnography monitoring and Standard monitoring in people with Hypoxia and Gastric Cancer, run by RenJi Hospital at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Hypoxia, Gastric Cancer, Gastric Polyp
What is being tested?
Capnography monitoring and Standard monitoring
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,800 participants
Where
3 sitesChina
Study dates
1 Sep 2021to 1 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Qilu Hospital of Shandong University

    Qingdao, Shandong, 250012

  • Renji Hospital

    Shanghai, Shanghai Municipality, 200127

  • Henan Provincial People's Hospital

    Zhenzhou, Henan, 450003

Other trials in China

About this study

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

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.

Being tested
Capnography monitoring, Standard monitoring
Keywords
Capnographic Monitoring, Hypoxia, Gastrointestinal endoscopy, Elderly patients, Propofol
Medical subject headings
Hypoxia, Stomach Neoplasms, Polyposis, Gastric, Colonic Polyps, Colonic Neoplasms, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Capnography monitoringDevice

    Standard monitoring and capnographic monitoring.

  • Standard monitoringDevice

    Standard monitoring but no capnographic monitoring

Study groups in NCT05030870
Study groupRoleWhat they receive
Capnographic monitoring groupExperimentalIn 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.
Receives: Device: Capnography monitoring; Device: Standard monitoring
Standard monitoring groupActive comparatorIn 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.
Receives: Device: Standard monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of hypoxia

    (75% ≤ SpO2 < 90% for <60 s)

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

Secondary outcomes (4)

  1. The incidence of sub-clinical respiratory depression

    (90% ≤ SpO2 < 95%)

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

  2. The incidence of severe hypoxia

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

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

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

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

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

  4. The incidence of other adverse events

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2021
  2. Study start1 Sep 2021
  3. Primary completion1 Sep 2022
  4. Study completion1 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05030870
Sponsor's protocol ID
RenjiH-20201201
Acronym
CapnoGI
Status last verified
Mar 2024
First submitted
20 Aug 2021
Last updated
19 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36918924

Questions about this trial

What is this clinical trial studying?

A study testing Capnography monitoring and Standard monitoring in people with Hypoxia and Gastric Cancer, run by RenJi Hospital at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of hypoxia (time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05030870, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.

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