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Effect of High-Flow Tracheal Oxygen on EELI

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06824220
Enrollment
11
Registered
2025-02-13
Start date
2024-12-01
Completion date
2025-03-31
Last updated
2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheostomized Patients

Keywords

end-expiratory lung impedance, high-flow tracheal oxygen, Tracheostomy

Brief 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. 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.

Interventions

DEVICEHigh-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.

Sponsors

Argentinian Intensive Care Society
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
End-Expiratory Lung ImpedanceFrom enrollment to the end of treatment at 120 minutes for each patientEnd-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

MeasureTime frameDescription
Respiratory rateFrom enrollment to the end of treatment at 120 minutes for each patientRespiratory rate refers to the number of breaths a person takes per minute.
Arterial oxygen saturationFrom enrollment to the end of treatment at 120 minutes for each patientArterial 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

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026