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HFNC Versus Conventional Oxygen Therapy in Prolonged Upper Gastrointestinal Endoscopy in the ICU

NCT06350864 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-10-29

No results posted yet for this study

Summary

Conventional supplemental oxygen therapy (COT) during upper gastrointestinal (UGI) endoscopy via nasal catheter is considered the standard practice in maintenance of oxygenation and prevention of hypoxia. However, it is still unclear if this oxygen delivery method is optimal in a prolonged (more than 15 minutes) procedure in patients admitted to the ICU. Because of shortage of data in this concern, this prospective, randomized, controlled clinical trial study will aim to evaluate and compare the efficacy of high-flow nasal cannula (HFNC) oxygen therapy versus COT in patients who will undergo prolonged either diagnostic or therapeutic UGI endoscopy in the intensive care unit (ICU) .

Conditions

  • Upper Gastrointestinal Bleeding

Interventions

DEVICE

High-flow nasal cannula (HFNC)

high flow cartridge and adult size nasal cannula: (flow range: 5-40L/minute, oxygen concentration (FiO2): 21-100%, temperature range: 33-39◦ C, humidity minimum of 12mg/liter)

DEVICE

Conventional nasal oxygen therapy (COT)

Adult size, single use nasal cannula

DEVICE

Upper gastrointestinal endoscopy (UGE) including gastroscopy

Upper gastrointestinal endoscopy (UGE) will be either diagnostic and/or therapeutic including variceal band ligation, endoscopic hemostasis as injection of bleeding peptic ulcers with adrenaline or bleeders control via either argon plasma coagulation (APC) or heater probe coagulation.

DEVICE

Upper gastrointestinal endoscopy (UGE) including Endoscopic ultrasound (EUA)

Upper gastrointestinal endoscopy (UGE) will be diagnostic

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Ahmed M Mohamed, MD · Ain Shames University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-10
Primary Completion
2024-09-01
Completion
2024-09-20
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06350864 on ClinicalTrials.gov