The Effect of High Flow Oxygen Therapy Via Tracheostomy on Diaphragm Function
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: High Flow Oxygen Therapy Tracheostomized patients will undergo a spontaneous breathing trial with high flow oxygen therapy. |
Device: High Flow Oxygen Therapy
A 30-minute spontaneous breathing trial using high flow oxygen therapy via tracheostomy.
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Active Comparator: T-piece Tracheostomized patients will undergo a spontaneous breathing trial with T-piece as a standard of care. |
Device: T-piece
A 30-minute spontaneous breathing trial using T-piece via tracheostomy.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Diaphragmatic function [30 minutes]
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.
- Diaphragmatic thickening fraction [30 minutes]
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.
Secondary Outcome Measures
- Tidal volume [30 minutes]
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.
- Respiratory frequence [30 minutes]
Differences in respiratory frequency between high flow oxygen therapy and T-piece will be assessed by respiratory rate measurement (breaths per minute).
Eligibility Criteria
Criteria
Inclusion Criteria:
- Mechanically ventilated patients with prolonged weaning and tracheostomy
Exclusion Criteria:
- pregnancy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Evangelismos Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
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- 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.
- 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.
- No 771 2019