Non Invasive End Tidal Carbon Dioxide Monitoring During Moderate Sedation
EtCO2
Non-invasive Carbon Dioxide Monitoring During Moderate Sedation at Different Oxygen Flow Rates in Patients Undergoing Endoscopic Retrograde Cholangio-pancreatography
1 other identifier
observational
120
1 country
1
Brief Summary
CO2 monitoring through non-invasive methods at different O2 flow rates may provide an early warning sign of hypoventilation during procedural sedation.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
Started Jun 2020
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMarch 18, 2022
March 1, 2022
1.5 years
April 28, 2020
March 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
End-tidal carbon dioxide
: end-tidal carbon dioxide (EtCO2) that is taken during different flows of oxygen(O2) supplementation will be measured.
During the procedure.
Secondary Outcomes (2)
Oxygen saturation.
During the procedure.
Haemodynamics as blood pressure.
During the procedure.
Study Arms (3)
2 liters
40 patients will receive O2 supply at rate of 2 liters per minute and then cabnographic and other measures will be recorded through out the procedure.
4 liters
40 patients will receive receive O2 supply at rate 4 liters per minute and then cabnographic and other measures will be recorded through out the procedure.
6 liters
: 40 patients will receive O2 supply at rate 6 liters per minute and then cabnographic and other measures will be recorded through out the procedure.
Interventions
DualGuard device (FlexiCare) which incorporate an endoscopy bite block with oxygen delivery and CO2 monitoring from both the mouth and nose simultaneously.
Eligibility Criteria
: Two days before surgery, patients will visit the outpatient clinic for history taken, clinical assessment and explanation about the study protocol. Laboratory investigations will be performed and patients will be informed that they can stop participation in the study at any time without any loss of service. Patients will receive conscious sedation via propofol 1.5 mg/kg and lidocaine 1 mg/kg and CO2 monitored through non-invasive method. At the end of the procedure, all patients will recover until full consciousness regains and they are able to follow verbal commands. After the desired spontaneous ventilation, the patients will be transferred to the recovery room.
You may qualify if:
- Age: Adult Patients aged 20-60 years.
- Sex: either male or female.
- ASA physical status I or II.
- Elective ERCP
You may not qualify if:
- Abnormal renal function test.
- History of asthma or COPD
- patients with a history of hypertension and diabetes.
- Cardiac patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university
Asyut, Egypt
Study Officials
- STUDY DIRECTOR
Mohamed Fathy
Assiut University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 28, 2020
First Posted
October 19, 2020
Study Start
June 1, 2020
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
March 18, 2022
Record last verified: 2022-03