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Tracheostomized PatientsNCT06824220

Effect of High-Flow Tracheal Oxygen on EELI

A study testing High-Flow Tracheal Oxygen in people with Tracheostomized Patients, run by Argentinian Intensive Care Society at 1 site in Argentina.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tracheostomized Patients
What is being tested?
High-Flow Tracheal Oxygen
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteArgentina
Study dates
1 Dec 2024to 31 Mar 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • neuromuscular or neurodegenerative pathology; contraindication for the use of Electrical Impedance Tomography, RASS > +1.

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • Sanatorio Parque

    Rosario, Santa Fe Province, S2000QGB

Other trials in Argentina

About this study

Official title: Effect of High-Flow Tracheal Oxygen on End-Expiratory Lung Impedance in Tracheostomized Patients

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.

Being tested
High-Flow Tracheal Oxygen
Keywords
end-expiratory lung impedance, high-flow tracheal oxygen, Tracheostomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-Flow Tracheal OxygenDevice

    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.

Study groups in NCT06824220
Study groupRoleWhat they receive
High-Flow Tracheal Oxygen 70 and 80 L/m in Tracheostomized PatientsOtherImplementation of High-Flow Tracheal Oxygen 70 and 80 L/m in Tracheostomized Patients for 20 minutes and End-Expiratory Lung Impedance evaluation
Receives: Device: High-Flow Tracheal Oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. End-Expiratory Lung Impedance

    End-Expiratory Lung Impedance refers to the electrical impedance of lung tissue measured at the end of expiration, serving as a non-invasive indicator of end-expiratory lung volume (EELV). In the context of high-flow oxygen therapy, changes in EELI reflect variations in lung aeration and recruitment in tracheostomized patients.

    Measured: From enrollment to the end of treatment at 120 minutes for each patient

Secondary outcomes (2)

  1. Respiratory rate

    Respiratory rate refers to the number of breaths a person takes per minute.

    Measured: From enrollment to the end of treatment at 120 minutes for each patient

  2. Arterial oxygen saturation

    Arterial oxygen saturation refers to the percentage of hemoglobin in the arterial blood that is bound to oxygen. It is a key indicator of oxygenation efficiency and respiratory function

    Measured: From enrollment to the end of treatment at 120 minutes for each patient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2025
  2. Study start1 Dec 2024
  3. Primary completion31 Mar 2025 (estimated)
  4. Study completion31 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06824220
Sponsor's protocol ID
#09122024
Status last verified
Feb 2025
First submitted
7 Feb 2025
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 26329355

  • 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.

    PubMed 33225971

  • 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.

    PubMed 30617626

  • 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.

    PubMed 31591659

  • 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.

    PubMed 27904928

  • 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.

    PubMed 27997805

  • 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.

    PubMed 38432703

  • 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.

    PubMed 28936675

  • 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.

    PubMed 24975297

  • 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.

    PubMed 36693401

  • 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.

    PubMed 32962998

Questions about this trial

What is this clinical trial studying?

A study testing High-Flow Tracheal Oxygen in people with Tracheostomized Patients, run by Argentinian Intensive Care Society at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

End-Expiratory Lung Impedance (time frame: From enrollment to the end of treatment at 120 minutes for each patient). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06824220, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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