High Flow Tracheal Oxygen for Weaning of Tracheostomized Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing Faisal Specialist Hospital & Research Center
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- High-flow tracheal oxygen (HFTO)
- Tracheal Mask (TM)
Treatment groups
88 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov