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NCT Number: NCT06824220

Effect of High-Flow Tracheal Oxygen on EELI

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Tracheostomized Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sanatorio Parque

Rosario, Santa Fe Province, S2000QGB, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-Flow Tracheal Oxygen

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.

Primary outcomes

  1. End-Expiratory Lung Impedance

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

    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.

Secondary outcomes

  1. Respiratory rate

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

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

  2. Arterial oxygen saturation

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

    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

Sponsors and collaborators

Lead sponsor

Argentinian Intensive Care Society

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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