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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Flow Oxygen Therapy | Active Comparator | Tracheostomized patients will undergo a spontaneous breathing trial with high flow oxygen therapy. |
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| T-piece | Active Comparator | Tracheostomized patients will undergo a spontaneous breathing trial with T-piece as a standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Flow Oxygen Therapy | Device | A 30-minute spontaneous breathing trial using high flow oxygen therapy via tracheostomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Respiratory frequence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina I Routsi, MD | Contact | 0030 6944508305 | chroutsi@hotmail.com | |
| Spyros Zakynthinos, MD | Contact | 0030 6977673885 | szakynthinos@yahoo.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27626706 | Background | 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. | |
| 21705883 |
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Participants will receive two treatments : high flow oxygen therapy and T-piece.
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| T-piece | Device | A 30-minute spontaneous breathing trial using T-piece via tracheostomy. |
|
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Differences in respiratory frequency between high flow oxygen therapy and T-piece will be assessed by respiratory rate measurement (breaths per minute).
| 30 minutes |
| 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. |
| 23344830 | 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. |
| 25981908 | 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. |
| 30617626 | 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. |
| 31591659 | 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. |
| 28857852 | 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. |
| 38681788 | Derived | 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. |