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Clinical Trials/NCT04758910
NCT04758910
Unknown
Not Applicable

The Effect of High Flow Oxygen Therapy Via Tracheostomy on Diaphragm Function in Patients With Prolonged Weaning From Mechanical Ventilation

Evangelismos Hospital0 sites30 target enrollmentMarch 1, 2021
ConditionsWeaning Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Weaning Failure
Sponsor
Evangelismos Hospital
Enrollment
30
Primary Endpoint
Diaphragmatic thickening fraction
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
July 30, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Evangelismos Hospital
Responsible Party
Principal Investigator
Principal Investigator

CHRISTINA ROUTSI

Professor in Medicine, National and Kapodistrian University of Athens, Athens, Greece

Evangelismos Hospital

Eligibility Criteria

Inclusion Criteria

  • Mechanically ventilated patients with prolonged weaning and tracheostomy

Exclusion Criteria

  • pregnancy

Outcomes

Primary Outcomes

Diaphragmatic thickening fraction

Time Frame: 30 minutes

Differences in diaphragmatic thickening fraction between high flow oxygen therapy and T-piece will be assessed using bedside ultrasound examination of the diaphragm thickness of diaphragmatic zone of apposition at end-inspiration and end-expiration and subsequent calculation of the difference between end-inspiratory and end-expiratory thickness divided by end-expiratory thickness.

Diaphragmatic function

Time Frame: 30 minutes

Differences in diaphragmatic function between high flow oxygen therapy and T-piece will be assessed by diaphragm excursion measurement (in cm) using bedside ultrasound examination of the diaphragm.

Secondary Outcomes

  • Respiratory frequence(30 minutes)
  • Tidal volume(30 minutes)

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