Clinical trial NCT04758910: The Effect of High Flow Oxygen Therapy Via Tracheostomy on Diaphragm Function
Official title: The Effect of High Flow Oxygen Therapy Via Tracheostomy on Diaphragm Function in Patients With Prolonged Weaning From Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weaning Failure
Keywords: prolonged weaning
tracheostomy
high flow oxygen therapy
Lead sponsor: Evangelismos Hospital
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will receive two treatments : high flow oxygen therapy and T-piece.
Primary purpose: TREATMENT

Brief summary: While the high flow oxygen therapy (HFOT) respiratory support system, delivered through nasal cannulas, has demonstrated clinical benefits on respiratory function, limited data exist on whether such effects are also present in HFOT through tracheostomy. Therefore, the aim of the proposed study is to examine the short-term effects of HFOT as opposed to oxygen therapy via T-piece on diaphragmatic function in tracheostomized patients with prolonged weaning from mechanical ventilation.

Detailed description: Critically ill patients who experience difficulties in weaning from the ventilator often undergo tracheostomy. These patients usually undergo spontaneous breathing trials receiving oxygen via T-piece. While the high flow oxygen therapy (HFOT) respiratory support system, delivered through nasal cannulas, has demonstrated clinical benefits on respiratory function, limited data exist on whether such effects are also present in HFOT through tracheostomy. Therefore, we plan to perform a study to examine the short-term effects of HFOT on diaphragmatic function in tracheostomized patients with prolonged weaning from mechanical ventilation.

After disconnection from the ventilator, patients will undergo a 30-minute spontaneous breathing trial receiving oxygen either conventionally via T-piece, or by HFOT delivered via tracheostomy, followed by a washout period of 15 min breathing through T-piece and 30 min receiving oxygen with the other modality in a randomized manner. At the start and end of each study period, patients will undergo an assessment through diaphragm ultrasonography, which includes excursion of diaphragmatic dome and thickness of diaphragmatic zone of apposition at end-inspiration and end-expiration. Subsequently, the diaphragmatic thickening fraction will be calculated as the difference between end-inspiratory and end-expiratory thickness divided by end-expiratory thickness. Also. arterial blood gases as well as respiratory rate (RR) and tidal volume (TV) (through a Wright's spirometer) will be measured.

Eligibility criteria: Inclusion Criteria:

* Mechanically ventilated patients with prolonged weaning and tracheostomy

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Diaphragmatic function
timeFrame: 30 minutes
measure: Diaphragmatic thickening fraction
timeFrame: 30 minutes
Secondary outcomes:
measure: Tidal volume
timeFrame: 30 minutes
measure: Respiratory frequence
timeFrame: 30 minutes
Other outcomes:
Locations:
Study officials:
References:
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