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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
High-flow tracheal oxygen (HFTO)
DeviceHigh-flow tracheal oxygen for weaning tracheosstomized mechanically ventilated patients
Tracheal Mask (TM)
DeviceStandard of care using tracheal mask (TM) oxygen for weaning tracheostomized mechanically ventilated patients
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: Standard of careActive comparator 1 intervention
Group B: Intervention armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1 Year2
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.
Time frame
1 Year3
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.
Time frame
1 YearSecondary outcomes
1
Ventilator-free days (VFDs) at day-30 from enrollment.
The number of days free from mechanical ventilation within the first 30 days post-enrollment will be recorded.
Time frame
30 days from enrollment2
Successful liberation from mechanical ventilation at 30-days from enrollment
Defined as spontaneous ventilation through tracheostomy without any mechanical ventilation during 7 consecutive days or discharged with spontaneous breathing, whichever comes first
Time frame
30 days from enrollment3
Mortality at 30 days.
Time frame
30 days from enrollment4
ICU length of stay at 30-days.
Time frame
30 days from enrollmentSponsors and contacts
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Source ClinicalTrials.gov