NCT04177927

Brief Summary

Does Endtidalcarbondioxide Monitoring in Gastrointestinal Endoscopy Have a Clinical Advantage?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

November 20, 2019

Last Update Submit

October 7, 2021

Conditions

Gastrointestinal Dysfunction

Outcome Measures

Primary Outcomes (1)

  • early detection of adverse events

    early detection of adverse events in patients who underwent sedation during gastrointestinal endoscopic intervention in the endoscopy unit

    30 minutes

Secondary Outcomes (2)

  • quality of recovery period

    120 minutes

  • Patients satisfaction

    24 hours

Study Arms (2)

endtidalcarbondioxide monitoring group

EXPERIMENTAL

The patients performed gastrointestinal endoscopy will be monitored with Capnostream 20p / Coviden for etCO2 (End tidal CO2), RR (Respitarory rate), SpO2 and PR (heart rate).

Device: Capnostream 20p / Coviden

Control Group

ACTIVE COMPARATOR

Rutine monitorization will be performed to control group of patients.

Device: Rutine monitoring

Interventions

Capnostream 20p / CovidenDEVICE

The special nasal canule is used for detection carbondioxide from breathe of patients

endtidalcarbondioxide monitoring group
Rutine monitoringDEVICE

peripheric Oxygen saturation is monitored.

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II
  • underwent gastrointestinal endoscopy

You may not qualify if:

  • existing heart and lung disease
  • liver and kidney failure
  • morbid obese
  • using psychiatric drugs
  • having malignancy
  • pregnant and lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.B.U. Sancaktepe Education and Research Hospital

Istanbul, 34785, Turkey (Türkiye)

Location

Study Officials

  • Nurten Bakan, doctor

    Ministry of Health University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 20, 2019

First Posted

November 26, 2019

Study Start

July 1, 2019

Primary Completion

July 1, 2020

Study Completion

October 1, 2020

Last Updated

October 8, 2021

Record last verified: 2021-10

Locations

TU(1)