NCT05652699

Effect of HFNO Therapy on Respiratory Effort After Extubation

High Flow Nasal Oxygen Therapy Re-evaluated from a Conceptual Point of View: Effect on Respiratory Effort and Lung Aeration After Extubation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Henrik Endeman · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Respiratory Failure
• Post Extubation Acute Respiratory Failure Requiring Reintubation

Interventions

Type	Name	Description
OTHER	High Flow Nasal Oxygen	Flow 60L/minute. FiO2 according to clinical protocol. Temperature highest tolerated by patient, starting with 37 degrees Celsius.
OTHER	Conventional Oxygen Therapy	Nasal Cannula, Venturi Mask or Non-rebreathing mask, according to local clinical protocols

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-10-22
• Completion: 2024-10-22
• First posted: 2022-12-15
• Last updated: 2025-01-17

Locations

2 sites across 1 country: Netherlands