High-flow Nasal Oxygenation Versus Standard Oxygenation for Gastrointestinal Endoscopy With Sedation in Obese Patients

NCT06231836 | Unknown

• 1 other identifier: FMASU Master 763/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hypoxaemia is a major complication during gastrointestinal endoscopy (GIE) procedures (upper/lower) when performed under deep sedation in the procedure room especially with a body mass index above 30 kg/m². The objective of the present work is to compare the use of High-flow nasal oxygenation (HFNO) with Standard oxygen therapy (SOT) in obese patient undergoing GIE.

Conditions

Prevention of Intraoperative Hypoxia

Outcome Measures

Primary Outcomes (1)

• occurence of hypoxia

  SpO2 \<90%

  during the procedure

Secondary Outcomes (6)

• occurence of hypoxia

  from recovery room admission till discharge up to one hour

• The rate of modifications of oxygen flow in both groups and of the FiO2 in the HFNO group.

  during the procedure

• number of participants needed to use mask ventilation or to perform any airway intervention

  during the procedure

• number of participants needed non- invasive ventilation, laryngeal mask airway or for intubation

  during the procedure

• number of participants needed to stop the procedure

  during the procedure

Study Arms (2)

High flow nasal cannula group

ACTIVE COMPARATOR

Device: High flow nasal cannula (HFNO)

Nasal cannula group

ACTIVE COMPARATOR

Device: nasal cannula

Interventions

High flow nasal cannula (HFNO) DEVICE

O2 is administered by HFNO with flow 70L/min and the FiO2 is set at 40%,

High flow nasal cannula group

nasal cannula DEVICE

O2 is administered by nasal cannula at 6L/min

Nasal cannula group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obese patient with body mass index (BMI) \>30
• Patients scheduled for GIE (upper and/or lower endoscopy), for which sedation with maintenance of spontaneous breathing is planned.
• Patients older than 18 years old.

You may not qualify if:

• Gastrointestinal endoscopy (GIE) performed in emergency.
• Necessity to intubate the patient for the procedure.
• Patient under oxygen therapy at home.
• Tracheostomised patient.
• Pregnancy.
• Patient not affiliated or excluded from social protection

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, 20, Egypt

Location

MeSH Terms

Interventions

Cannula

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 30, 2024
• Study Start: January 20, 2024
• Primary Completion: July 20, 2024
• Study Completion: July 20, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)