High Flow Tracheal Oxygen for Weaning of Tracheostomized Patients

NCT07559591 | Not Yet Recruiting DMC

• 1 other identifier: RAC# 2251192
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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. 1.To assess the feasibility of conducting a larger RCT as primary objective.
2. 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

Keywords

tracheostomized patients; tracheostomy; mechanical ventilation weaning; high flow tracheal oxygen; mechanical ventilation liberation; critically ill

Outcome Measures

Primary Outcomes (3)

• Consent Rate

  A successful consent rate will be defined as ≥70% of SDMs or patients approached to consent, agreeing to participate in the trial. This will be calculated as the proportion of substitute decision makers (SDMs) or patients who consent to participate out of those approached.

  1 Year

• Recruitment Rate

  A successful recruitment rate will be defined as achieving our target enrolment of 88 patients or recruiting at least 2 patients per month throughout the duration of the trial. The number of patients recruited per month will be tracked to ensure the target of 2 patients per month is met.

  1 Year

• Protocol Adherence

  A successful adherence will be defined as ≥ 75% of patients receiving HFTO in the intervention arm and ≥ 75% of patients receiving TM in the control arm (crossover in the control arm \<25%). This would be calculated as the proportion of patients assigned to the intervention arm that received HFTO, and the proportion of those patients assigned to the control arm receiving TM.

  1 Year

Secondary Outcomes (9)

• Ventilator-free days (VFDs) at day-30 from enrollment.

  30 days from enrollment

• Successful liberation from mechanical ventilation at 30-days from enrollment

  30 days from enrollment

• Mortality at 30 days.

  30 days from enrollment

• ICU length of stay at 30-days.

  30 days from enrollment

• Hospital length of stay at 30-days.

  30 days from enrollment

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

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

Device: Tracheal Mask (TM)

Intervention arm

EXPERIMENTAL

High-flow tracheal oxygen therapy (HFTO) for weaning tracheostomized mechanically ventilated patients

Device: High-flow tracheal oxygen (HFTO)

Interventions

High-flow tracheal oxygen (HFTO) DEVICE

High-flow tracheal oxygen for weaning tracheosstomized mechanically ventilated patients

Also known as: HFTO

Intervention arm

Tracheal Mask (TM) DEVICE

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

Also known as: tracheal mask

Standard of care

Eligibility Criteria

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

You may qualify if:

• Adults ≥ 18 years of age
• Intensive care unit (ICU) patients with tracheostomy inserted during the index ICU admission.
• Mechanically ventilated for ≤60 days.
• Successful spontaneous breathing trial for 1 hour.

You may not qualify if:

• Planned tracheostomy post head and neck surgery with ICU stay less than 48 hours
• Patient transferred from another hospital only if the intubation and tracheostomy dates are unavailable, otherwise would be eligible.
• Patient with an imminent plan for palliation and comfort care.
• Patient or substitute decision-maker declines consent to the study.
• The treating physician declines consent to the study.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital and Research Centre

Riyadh, Saudi Arabia

Location

Related Publications (1)

• Al Duhailib Z, Hajja A, Shacfe G, Nassar W, Tlayjeh M, Alshalawi M, Hegazy AF, Rochwerg B, Slessarev M. High-Flow Tracheal Oxygen for Weaning Mechanically Ventilated Tracheostomized Critically Ill Patients: A Retrospective Study. Acta Anaesthesiol Scand. 2025 Sep;69(8):e70104. doi: 10.1111/aas.70104.

  PMID: 40790546 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zainab Al Duhailib, MBBS, MSc, EDIC

  King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zainab Al Duhailib, MBBS, MSc, EDIC

CONTACT

00966112162919; zainajd@gmail.com

Kafa Abuhdeeb

CONTACT

00966112162919; kabuhdeeb@kfshrc.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Critical Care Medicine

Model Details: Pilot single-center, parallel-group, open-label feasibility randomized controlled trial

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)