High Flow Nasal Oxygen
OtherFlow 60L/minute. FiO2 according to clinical protocol. Temperature highest tolerated by patient, starting with 37 degrees Celsius.
Other names: High Flow Nasal Cannula, Nasal High Flow Therapy
NCT Number: NCT05652699
Rationale: Despite the lack of clear clinical protocols, High Flow Nasal Oxygen (HFNO) is used as post-extubation respiratory support. Although HFNO seems to reduce the need for re-intubation, scepticism on its use persists as the mechanism of action in post-extubation patients remains undefined. Monitoring weaning from invasive mechanical ventilation while monitoring respiratory effort might help to determine the added value of HFNO surrounding extubation. We hypothesize that HFNO, compared to conventional oxygen therapy (COT), prevents de-recruitment of the lung and reduces respiratory effort, and so provides a physiologic clarification for the reduction in the need for reintubation.
Objective: Determine the physiological effect of HFNO compared to COT in the extubation phase regarding respiratory effort and lung aeration.
Study design: A physiologic, randomized clinical study comparing two standard of clinical care therapies.
Study population: Adult patients on invasive mechanical ventilation (IMV) for >72 hours, who are scheduled for extubation.
Intervention (if applicable): Before extubation, patients are randomized to receive COT (reference group) or HFNO as oxygenation regimen after extubation.
Main study parameters/endpoints: The main outcome is the difference in change in lung respiratory muscle effort (mean ΔPES) at 24 hours post-extubation between the study groups. Secondary parameters are differences in changes in respiratory effort at 2 and 4 hours post-extubation, difference in change in lung aeration (mean ΔEELI), differences in tidal volume, dyspnea score, and respiratory and sputum parameters between patients undergoing different post-extubation oxygenation regimens.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Erasmus MC, Rotterdam, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Flow 60L/minute. FiO2 according to clinical protocol. Temperature highest tolerated by patient, starting with 37 degrees Celsius.
Other names: High Flow Nasal Cannula, Nasal High Flow Therapy
Nasal Cannula, Venturi Mask or Non-rebreathing mask, according to local clinical protocols
Time frame: At 24 hours after extubation
The difference between groups in change in ΔPES in patients 24 hours post-extubation.
Time frame: At 2 and 4 hours post-extubation
The difference between groups in change in ΔPES after extubation
Time frame: At 2, 4 and 24 hours after extubation
Difference between the groups in change in mean ∆EELIglobal
Time frame: At 2,4 and 24 hours after extubation
The difference between the groups in mean pressure-time product (PTPES) compared to baseline.
Time frame: At 2, 4 and 24 hours after extubation
∆VARt, ∆EELIdependent, ∆EELInon-dependent compared to baseline (impedance on IMV).
Time frame: At 2, 4 and 24 hours after extubation
Time frame: Within 7 days post-extubation
Treatment escalation
Time frame: Within 7 days post-extubation
Treatment escalation
Time frame: Within 7 days post-extubation
Treatment escalation
Time frame: Within 7 days post-extubation
Survival rates
Time frame: At 2 and 24 hours after extubation
Difference in sputum aspect and sputum clearance between the study groups, assessed with a 5-point likert scale.
Time frame: At 2 and 24 hours after extubation
Difference in dyspnea sensation between the groups, measured with Visual Analog Scale (VAS, ranging from 0 = No dyspnea until 10 = maximum dyspnea).
Henrik Endeman
Other
High Flow Nasal Oxygen Therapy Re-evaluated from a Conceptual Point of View: Effect on Respiratory Effort and Lung Aeration After Extubation
Acronym: T-REX
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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