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

Weaning Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04758910
• Other study ID #: No 771 2019
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: July 30, 2021

Study information

• Verified date: February 2021
• Source: Evangelismos Hospital
• Contact: Christina I Routsi, MD
• Phone: 0030 6944508305
• Email: chroutsi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mechanically ventilated patients with prolonged weaning and tracheostomy

Exclusion Criteria:

• pregnancy

Related Conditions & MeSH terms

• Weaning Failure

Intervention

Device:
• High Flow Oxygen Therapy
A 30-minute spontaneous breathing trial using high flow oxygen therapy via tracheostomy.
• T-piece
A 30-minute spontaneous breathing trial using T-piece via tracheostomy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Evangelismos Hospital

References & Publications (7)

Béduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grangé 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 (Réseau Européen de Recherche en Ventilation Artificielle) Network ‡. 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. — View Citation

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. — View Citation

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, Béduneau G, Delétage-Métreau 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Tidal volume	Differences 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.	30 minutes
Secondary	Respiratory frequence	Differences in respiratory frequency between high flow oxygen therapy and T-piece will be assessed by respiratory rate measurement (breaths per minute).	30 minutes