High-Flow Tracheal Oxygen During Spontaneous Breathing Trial

ConditionsMechanical Ventilation Weaning Spontaneous Breathing Trial High Flow Oxygen Therapy

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorArgentinian Intensive Care Society

About this trial

The purpose of this study is to find out whether high-flow tracheal oxygen (HFTO) delivered at flows greater than 60 L/min can increase end-expiratory lung volume (EELV) in intubated patients during a spontaneous breathing trial (SBT).

Weaning from mechanical ventilation can be difficult, especially in patients at higher risk of failure. During an SBT, losing positive end-expiratory pressure (PEEP) can cause the lungs to lose volume and make breathing harder by increasing the work of breathing (WOB). HFTO may help reduce the work of breathing, but previous studies using flows of 30-60 L/min did not consistently show an increase in EELV. Higher flows may create more airway pressure.

Therefore, the main question this study is trying to answer is: In intubated patients during an SBT, does HFTO at flows greater than 60 L/min increase EELV? The hypothesis is that HFTO at flows above 60 L/min will increase EELV during the SBT.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Invasive mechanical ventilation ≥ 24 hours

Presence of esophageal balloon catheter

Meets criteria to start an SBT

Disqualifiers

Neuromuscular or neurodegenerative disease

contraindication to electrical impedance tomography (e.g., implantable defibrillator)

Impossible to place EIT electrode belt (e.g., wound dressings or chest drains)

Flow intolerance

Trial design

Design model

Crossover

Treatments tested in this trial

T-piece, HFTO 50, washout, HFTO 70, washout, PSV.
Device
Participants randomized to this Sequence receive the following conditions during a spontaneous breathing trial (SBT): T-piece (baseline) - 15 minutes High-flow tracheal oxygen (HFTO) at 50 L/min - 15 minutes Washout on T-piece - 15 minutes HFTO at 70 L/min - 15 minutes Washout on T-piece - 15 minutes Pressure support ventilation (PSV) 7 cmH₂O / PEEP 0 cmH₂O - 15 minutes Throughout the sequence, end-expiratory lung impedance (EELI), work of breathing (esophageal pressure-derived parameters), respiratory rate, SpO₂, hemodynamic variables, dyspnea, and diaphragmatic thickening fraction (DTF) are measured. This is one of two randomized crossover sequences; all participants receive all conditions in the order assigned by randomization.
T-piece, HFTO 70, washout, HFTO 50, washout, PSV.
Device
Participants randomized to this Sequence receive the following conditions during a spontaneous breathing trial (SBT): T-piece (baseline) - 15 minutes High-flow tracheal oxygen (HFTO) at 70 L/min - 15 minutes Washout on T-piece - 15 minutes HFTO at 50 L/min - 15 minutes Washout on T-piece - 15 minutes Pressure support ventilation (PSV) 7 cmH₂O / PEEP 0 cmH₂O - 15 minutes Throughout the sequence, end-expiratory lung impedance (EELI), work of breathing (esophageal pressure-derived parameters: ΔPes, PTPes, PTPes-min), respiratory rate, SpO₂, hemodynamic variables, dyspnea, and diaphragmatic thickening fraction (DTF) are measured. This is one of two randomized crossover sequences; all participants receive all conditions in the order assigned by randomization.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Sequence A (HFTO 50 → HFTO 70)Experimental treatment 1 intervention

Group B: Sequence B (HFTO 70 → HFTO 50)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in end-expiratory lung impedance (EELI) during spontaneous breathing trial

Change in global end-expiratory lung impedance (ΔEELI; arbitrary units), measured by electrical impedance tomography (EIT), expressed as tidal variation of the first stable respiratory cycle, among four conditions in intubated adult patients during a spontaneous breathing trial: T-piece, high-flow tracheal oxygen (HFTO) at 50 L/min, HFTO at 70 L/min, and pressure support ventilation (PSV) 7 cmH₂O / PEEP 0 cmH₂O. Because this is a randomized crossover study, the primary comparison is within-subject across conditions.

Time frame

Baseline (t0, T-piece); after 15 minutes of HFTO 50 L/min; after 15 minutes of HFTO 70 L/min; after 15 minutes of PSV 7 cmH₂O/PEEP 0 cmH₂O; with 15 minutes T-piece washout periods between conditions.

Secondary outcomes

Change in esophageal pressure swing

Change in esophageal pressure swing (ΔPes; units cmH2O) across conditions (T-piece, HFTO 50 L/min, HFTO 70 L/min, PSV 7 cmH₂O / PEEP 0 cmH₂O).

Time frame

Change in Diaphragmatic Thickening Fraction (DTF)

Change in diaphragmatic thickening fraction (DTF; Units percentage) measured by ultrasonography, calculated as: DTF = \[(thickness at end-inspiration - thickness at end-expiration) / thickness at end-expiration\] × 100.

Time frame

Baseline (t0, T-piece); at the end of 15 minutes of HFTO 50 L/min; at the end of 15 minutes of HFTO 70 L/min; at the end of 15 minutes of PSV 7 cmH₂O/PEEP 0 cmH₂O; with 15 minutes T-piece washout periods between conditions.

Respiratory rate

Number of ventilatory cicles per minute

Time frame

Baseline (t0, T-piece); after 15 minutes of HFTO 50 L/min; after 15 minutes of HFTO 70 L/min; after 15 minutes of PSV 7 cmH₂O/PEEP 0 cmH₂O; with T-piece washout periods between conditions.

Other outcomes

Days of invasive mechanical ventilation to weaning

Days of invasive mechanical ventilation from the intubation to the first weaning attempt

Time frame

Baseline

ICU length of stay

Duration of stay in the intensive care unit (ICU) from ICU admission to ICU discharge or death, whichever occurs first (Units; days)

Time frame

From ICU admission through ICU discharge or death, assessed up to [28 days] after enrollment/randomization.

ICU mortality

Number of participants who died in the ICU.

Time frame

Through ICU discharge or up to [28 days] after enrollment/randomization.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Argentinian Intensive Care Society

Lead sponsor

Source ClinicalTrials.gov

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