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The Effect of High Flow Oxygen Therapy Via Tracheostomy on Diaphragm Function

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04758910
Enrollment
30
Registered
2021-02-17
Start date
2021-03-01
Completion date
2021-07-30
Last updated
2021-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weaning Failure

Keywords

prolonged weaning, tracheostomy, high flow oxygen therapy

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.

Interventions

A 30-minute spontaneous breathing trial using high flow oxygen therapy via tracheostomy.

DEVICET-piece

A 30-minute spontaneous breathing trial using T-piece via tracheostomy.

Sponsors

Evangelismos Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants will receive two treatments : high flow oxygen therapy and T-piece.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Mechanically ventilated patients with prolonged weaning and tracheostomy

Exclusion criteria

* pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Diaphragmatic function30 minutesDifferences 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.
Diaphragmatic thickening fraction30 minutesDifferences 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.

Secondary

MeasureTime frameDescription
Tidal volume30 minutesDifferences in tidal volume between high flow oxygen therapy and T-piece will be assessed by tidal volume (in mL) measurement by a Wright's spirometer.
Respiratory frequence30 minutesDifferences in respiratory frequency between high flow oxygen therapy and T-piece will be assessed by respiratory rate measurement (breaths per minute).

Contacts

Primary ContactChristina I Routsi, MD
chroutsi@hotmail.com0030 6944508305
Backup ContactSpyros Zakynthinos, MD
szakynthinos@yahoo.com0030 6977673885

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026