NCT04481308

Brief Summary

CO2 monitoring through non-invasive methods to provide an early warning of hypoventilation during procedural sedation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

July 14, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
2.2 years until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

1 month

First QC Date

July 14, 2020

Last Update Submit

February 14, 2022

Conditions

Patient Monitoring

Keywords

Non-InvasiveCO2 MonitoringConscious SedationAdult ERCP

Outcome Measures

Primary Outcomes (1)

  • mparison between CO2 measurement from non-invasive method (Dual guard) during conscious sedation for ERCP and invasive method (arterial blood gases).

    mparison between CO2 measurement from non-invasive method (Dual guard) during conscious sedation for ERCP and invasive method (arterial blood gases).

    october 2020

Interventions

propofol (2 mg/kg) and fentanyl (1ug/kg) and 4 liters O2 flow through nasal cannulaDRUG

propofol (2 mg/kg) and fentanyl (1ug/kg) and 4 liters O2 flow through nasal cannula

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adult patients aged 20-50 years.

You may qualify if:

  • Adult patients aged 20-50 years.
  • Males or females.
  • Elective Endoscopic Retrograde Cholangiopancreatography Patients

You may not qualify if:

  • Patient with abnormal renal function test.
  • Patient with history of chronic chest disease like asthma or Chronic obstructed pulmonary diseases.
  • Patients with a history of systemic illness like hypertension and diabetes.
  • Cardiac patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medicin

Asyut, Egypt

RECRUITING

Samar

Asyut, Egypt

RECRUITING

MeSH Terms

Interventions

PropofolFentanyl

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Samar Fouad

CONTACT

01122205439Samarfouad00@gmail.com

Mohamed Abdel-Moneim Bakr

CONTACT

01223213370bakr@aun.eu.eg

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of anesthesia and intensive care

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 22, 2020

Study Start

October 1, 2022

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

February 16, 2022

Record last verified: 2022-02

Locations

EG(2)