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High Flow Tracheal Oxygen for Weaning of Tracheostomized Patients

NCT07559591 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-04-30

No results posted yet for this study

Summary

In this pilot randomized controlled trial (RCT), the investigators aim to explore the feasibility of conducting a powered RCT that examines the efficacy and safety of high flow tracheal oxygen (HFTO) in weaning critically ill tracheostomy patients from mechanical ventilation.

Objective of the study

1. To assess the feasibility of conducting a larger RCT as primary objective.
2. To explore the effect of using HFTO in mechanically ventilated tracheostomized critically ill patients on ventilator-free days (VFD) compared to standard of care method using tracheal mask (TM) as secondary objective.

Conditions

  • Tracheostomized Patients
  • Mechanical Ventilation Weaning
  • High Flow Oxygen Therapy

Interventions

DEVICE

High-flow tracheal oxygen (HFTO)

High-flow tracheal oxygen for weaning tracheosstomized mechanically ventilated patients

DEVICE

Tracheal Mask (TM)

Standard of care using tracheal mask (TM) oxygen for weaning tracheostomized mechanically ventilated patients

Sponsors & Collaborators

  • King Faisal Specialist Hospital & Research Center

    lead OTHER

Principal Investigators

  • Zainab Al Duhailib, MBBS, MSc, EDIC · King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Saudi Arabia

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 NCT07559591 on ClinicalTrials.gov