Effect of High-Flow Tracheal Oxygen on EELI

NCT ID: NCT06824220

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-03-31

Brief Summary

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The goal of this analytical experimental study is to evaluate whether high-flow tracheal oxygen therapy at flow rates above 60 L/min increases end-expiratory lung impedance in tracheostomized patients in the intensive care unit. The main question it aims to answer is whether high-flow tracheal oxygen therapy improves end-expiratory lung impedance in tracheostomized patients.

This study will be conducted in the Intensive Care Unit of Sanatorio Parque in Rosario, Santa Fe, Argentina, between December 1, 2024, and March 31, 2025. The participant population consists of adult ICU patients (≥18 years old) who are tracheostomized, have undergone at least 10 days of mechanical ventilation, and can tolerate spontaneous breathing for at least 12 hours.

By analyzing the effects of high-flow tracheal oxygen therapy on lung function, this study aims to generate valuable insights into its physiological impact, potentially influencing clinical management strategies for tracheostomized patients in intensive care settings.

Detailed Description

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Conditions

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Tracheostomized Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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High-Flow Tracheal Oxygen 70 and 80 L/m in Tracheostomized Patients

Implementation of High-Flow Tracheal Oxygen 70 and 80 L/m in Tracheostomized Patients for 20 minutes and End-Expiratory Lung Impedance evaluation

Group Type OTHER

High-Flow Tracheal Oxygen

Intervention Type DEVICE

High-Flow Tracheal Oxygen is the use of high oxygen flows in tracheostomized patients. Unlike conventional oxygen therapy which is performed through siliconized nasal prongs, this is done through a connector directly on the tracheostomy tube.

Interventions

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High-Flow Tracheal Oxygen

High-Flow Tracheal Oxygen is the use of high oxygen flows in tracheostomized patients. Unlike conventional oxygen therapy which is performed through siliconized nasal prongs, this is done through a connector directly on the tracheostomy tube.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* signed informed consent; ability to tolerate spontaneous breathing for at least 12 hours; arterial oxygen pressure (PaO2) ≥ 60 mm hg or pulse oxygen saturation (SpO2) \> 90%; corrected metabolic disorders ph ≥ 7.32; hemodynamically stable.

Exclusion Criteria

* neuromuscular or neurodegenerative pathology; contraindication for the use of Electrical Impedance Tomography, RASS \> +1.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Argentinian Intensive Care Society

OTHER

Sponsor Role lead

Responsible Party

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Gustavo Plotnikow

Hospital Británico de Buenos Aires

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sanatorio Parque

Rosario, Santa Fe Province, Argentina

Site Status

Countries

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Argentina

References

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Parke RL, Bloch A, McGuinness SP. Effect of Very-High-Flow Nasal Therapy on Airway Pressure and End-Expiratory Lung Impedance in Healthy Volunteers. Respir Care. 2015 Oct;60(10):1397-403. doi: 10.4187/respcare.04028. Epub 2015 Sep 1.

Reference Type BACKGROUND
PMID: 26329355 (View on PubMed)

Basile MC, Mauri T, Spinelli E, Dalla Corte F, Montanari G, Marongiu I, Spadaro S, Galazzi A, Grasselli G, Pesenti A. Nasal high flow higher than 60 L/min in patients with acute hypoxemic respiratory failure: a physiological study. Crit Care. 2020 Nov 23;24(1):654. doi: 10.1186/s13054-020-03344-0.

Reference Type BACKGROUND
PMID: 33225971 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30617626 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31591659 (View on PubMed)

Corley A, Edwards M, Spooner AJ, Dunster KR, Anstey C, Fraser JF. High-flow oxygen via tracheostomy improves oxygenation in patients weaning from mechanical ventilation: a randomised crossover study. Intensive Care Med. 2017 Mar;43(3):465-467. doi: 10.1007/s00134-016-4634-7. Epub 2016 Nov 30. No abstract available.

Reference Type BACKGROUND
PMID: 27904928 (View on PubMed)

Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC.

Reference Type BACKGROUND
PMID: 27997805 (View on PubMed)

Rose L, Messer B. Prolonged Mechanical Ventilation, Weaning, and the Role of Tracheostomy. Crit Care Clin. 2024 Apr;40(2):409-427. doi: 10.1016/j.ccc.2024.01.008. Epub 2024 Feb 2.

Reference Type BACKGROUND
PMID: 38432703 (View on PubMed)

Fernandez MM, Gonzalez-Castro A, Magret M, Bouza MT, Ibanez M, Garcia C, Balerdi B, Mas A, Arauzo V, Anon JM, Ruiz F, Ferreres J, Tomas R, Alabert M, Tizon AI, Altaba S, Llamas N, Fernandez R. Reconnection to mechanical ventilation for 1 h after a successful spontaneous breathing trial reduces reintubation in critically ill patients: a multicenter randomized controlled trial. Intensive Care Med. 2017 Nov;43(11):1660-1667. doi: 10.1007/s00134-017-4911-0. Epub 2017 Sep 22.

Reference Type BACKGROUND
PMID: 28936675 (View on PubMed)

Navalesi P, Frigerio P, Patzlaff A, Haussermann S, Henseke P, Kubitschek M. Prolonged weaning: from the intensive care unit to home. Rev Port Pneumol. 2014 Sep-Oct;20(5):264-72. doi: 10.1016/j.rppneu.2014.04.006. Epub 2014 Jun 26.

Reference Type BACKGROUND
PMID: 24975297 (View on PubMed)

Pham T, Heunks L, Bellani G, Madotto F, Aragao I, Beduneau G, Goligher EC, Grasselli G, Laake JH, Mancebo J, Penuelas O, Piquilloud L, Pesenti A, Wunsch H, van Haren F, Brochard L, Laffey JG; WEAN SAFE Investigators. Weaning from mechanical ventilation in intensive care units across 50 countries (WEAN SAFE): a multicentre, prospective, observational cohort study. Lancet Respir Med. 2023 May;11(5):465-476. doi: 10.1016/S2213-2600(22)00449-0. Epub 2023 Jan 21.

Reference Type BACKGROUND
PMID: 36693401 (View on PubMed)

Mussa CC, Gomaa D, Rowley DD, Schmidt U, Ginier E, Strickland SL. AARC Clinical Practice Guideline: Management of Adult Patients with Tracheostomy in the Acute Care Setting. Respir Care. 2021 Jan;66(1):156-169. doi: 10.4187/respcare.08206. Epub 2020 Sep 22.

Reference Type BACKGROUND
PMID: 32962998 (View on PubMed)

Other Identifiers

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#09122024

Identifier Type: -

Identifier Source: org_study_id

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