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

NCT ID: NCT04758910

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-07-30

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.

Conditions

Weaning Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High Flow Oxygen Therapy

Tracheostomized patients will undergo a spontaneous breathing trial with high flow oxygen therapy.

Group Type: ACTIVE_COMPARATOR

High Flow Oxygen Therapy

Intervention Type: DEVICE

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

T-piece

Tracheostomized patients will undergo a spontaneous breathing trial with T-piece as a standard of care.

Group Type: ACTIVE_COMPARATOR

T-piece

Intervention Type: DEVICE

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

Interventions

High Flow Oxygen Therapy

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

Intervention Type: DEVICE

T-piece

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

Intervention Type: DEVICE

Other Intervention Names

Standard of care

Eligibility Criteria

Inclusion Criteria

• Mechanically ventilated patients with prolonged weaning and tracheostomy

Exclusion Criteria

• pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evangelismos Hospital

OTHER

Sponsor Role: lead

Responsible Party

CHRISTINA ROUTSI

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Christina I Routsi, MD

Role: CONTACT

chroutsi@hotmail.com

0030 6944508305

Spyros Zakynthinos, MD

Role: CONTACT

szakynthinos@yahoo.com

0030 6977673885

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Other Identifiers

No 771 2019

Identifier Type: -

Identifier Source: org_study_id