Effect of High-Flow Humidified Oxygen on Ventilatory Work During the Spontaneous Breathing Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble

About this trial

Weaning from mechanical ventilation (MV) accounts for a significant portion of the total MV duration, and failure to extubate or delayed extubation increases complications (particularly Ventilator-Associated Pneumonia (VAP)) and mortality. Standard tests (T-piece, Spontaneous Ventilation with Inspiratory Assistance (SV-IA)) have not demonstrated clear superiority, and the T-piece is still widely used despite its limitations. High-flow oxygen (HFO) may reduce ventilatory work and facilitate secretion clearance; however, there is a lack of physiological data in humans with an endotracheal tube in place. This study aims to address this gap prior to a subsequent clinical evaluation.

An experimental, prospective, single-center, 3-period crossover study with randomized sequence order and single-blind design (primary endpoint assessment and statistical analysis were conducted in a blinded manner).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patient, of legal age

On invasive mechanical ventilation for more than 48 hours

Age > 65 years

Chronic respiratory disease

Disqualifiers

Resuscitation-associated neuromyopathy

History of neuromuscular disease

Admission for a neurological condition

Subjects currently excluded from another study,

Trial design

Design model

Crossover

Treatments tested in this trial

  • T piece

    Device

    The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery

  • PSV

    Device

    The endotracheal tube will be connected to the pneumotachograph. The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.

  • HFO

    Device

    The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher \& Paykel, Optiflow+®) will be connected to the pneumotachograph. The OHD flow rate will be set to 50 L/min. A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.

Treatment groups

30 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: TP/HFO/PSVOther 3 interventions
Group B: TP/PSV/HFOOther 3 interventions
Group C: PSV/HFO/TPOther 3 interventions
Group D: PSV/TP/HFOOther 3 interventions
Group E: HFO/TP/PSVOther 3 interventions
Group F: HFO/PSV/TPOther 3 interventions

Trial outcomes

Primary outcomes

1

Respiratory work during the weaning test, defined as the energy expended to inhale and exhale a respiratory gas, measured in joules per liter per minute.

Time frame
190 min

Secondary outcomes

1

Tidal Volume

Time frame
190 min
2

Total Positive End-Expiratory Pressure

Time frame
190 min
3

Respiratory Rate

Time frame
190 min
4

minute ventilation

Time frame
190 min

Other outcomes

1

Percentage of patients extubated following the series of weaning trials

Time frame
190 min
2

Percentage of reintubations within 48 hours after extubation

Time frame
52 hours

Locations

This trial has no locations.

Sponsors and contacts

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