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

NCT04758910 | Unknown

• 1 other identifier: No 771 2019
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Weaning Failure

Keywords

prolonged weaning; tracheostomy; high flow oxygen therapy

Outcome Measures

Primary Outcomes (2)

• Diaphragmatic function

  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.

  30 minutes

• Diaphragmatic thickening fraction

  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.

  30 minutes

Secondary Outcomes (2)

• Tidal volume

  30 minutes

• Respiratory frequence

  30 minutes

Study Arms (2)

High Flow Oxygen Therapy

ACTIVE COMPARATOR

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

Device: High Flow Oxygen Therapy

T-piece

ACTIVE COMPARATOR

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

Device: T-piece

Interventions

High Flow Oxygen Therapy DEVICE

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

High Flow Oxygen Therapy

T-piece DEVICE

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

Also known as: Standard of care

T-piece

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mechanically ventilated patients with prolonged weaning and tracheostomy

You may not qualify if:

• pregnancy

Sponsors & Collaborators

• Evangelismos Hospital: lead

Related Publications (8)

• Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.

  PMID: 27626706 BACKGROUND

• Kim WY, Suh HJ, Hong SB, Koh Y, Lim CM. Diaphragm dysfunction assessed by ultrasonography: influence on weaning from mechanical ventilation. Crit Care Med. 2011 Dec;39(12):2627-30. doi: 10.1097/CCM.0b013e3182266408.

  PMID: 21705883 BACKGROUND

• Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.

  PMID: 23344830 BACKGROUND

• Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

  PMID: 25981908 BACKGROUND

• Stripoli T, Spadaro S, Di Mussi R, Volta CA, Trerotoli P, De Carlo F, Iannuzziello R, Sechi F, Pierucci P, Staffieri F, Bruno F, Camporota L, Grasso S. High-flow oxygen therapy in tracheostomized patients at high risk of weaning failure. Ann Intensive Care. 2019 Jan 7;9(1):4. doi: 10.1186/s13613-019-0482-2.

  PMID: 30617626 BACKGROUND

• Natalini D, Grieco DL, Santantonio MT, Mincione L, Toni F, Anzellotti GM, Eleuteri D, Di Giannatale P, Antonelli M, Maggiore SM. Physiological effects of high-flow oxygen in tracheostomized patients. Ann Intensive Care. 2019 Oct 7;9(1):114. doi: 10.1186/s13613-019-0591-y.

  PMID: 31591659 BACKGROUND

• Delorme M, Bouchard PA, Simon M, Simard S, Lellouche F. Effects of High-Flow Nasal Cannula on the Work of Breathing in Patients Recovering From Acute Respiratory Failure. Crit Care Med. 2017 Dec;45(12):1981-1988. doi: 10.1097/CCM.0000000000002693.

  PMID: 28857852 BACKGROUND

• Lytra E, Kokkoris S, Poularas I, Filippiadis D, Cokkinos D, Exarhos D, Zakynthinos S, Routsi C. The effect of high-flow oxygen via tracheostomy on respiratory pattern and diaphragmatic function in patients with prolonged mechanical ventilation: A randomized, physiological, crossover study. J Intensive Med. 2024 Jan 4;4(2):202-208. doi: 10.1016/j.jointm.2023.11.008. eCollection 2024 Apr.

  PMID: 38681788 DERIVED

Central Study Contacts

Christina I Routsi, MD

CONTACT

0030 6944508305; chroutsi@hotmail.com

Spyros Zakynthinos, MD

CONTACT

0030 6977673885; szakynthinos@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Medicine, National and Kapodistrian University of Athens, Athens, Greece

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

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: February 17, 2021
• Study Start: March 1, 2021
• Primary Completion: May 30, 2021
• Study Completion: July 30, 2021
• Last Updated: February 17, 2021

Record last verified: 2021-02