Effect of HFNO Therapy on Respiratory Effort After Extubation

Not Applicable

Completed

• Conditions: Respiratory Failure; Post Extubation Acute Respiratory Failure Requiring Reintubation
• Interventions: Other: Conventional Oxygen Therapy; Other: High Flow Nasal Oxygen

• Registration Number: NCT05652699
• Lead Sponsor: Henrik Endeman

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-11-23
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-15
• Primary Completion: 2024-10-22
• Study Completion: 2024-10-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Aged ≥ 18 years
• Receiving IMV > 48 hours for any cause
• Successfully completing spontaneous breathing trial (SBT) as per local clinical guideline
• Provided written informed consent, through legal representatives on indication

Exclusion Criteria

• Any clinical situation preventing appropriate execution of study procedures
• The presence of a tracheostomy
• Any feature that precludes HFNO-initiation
• Indication for NIV such as hypercapnia at end of SBT, or Obstructive/central Sleep Apnoea Syndrome or Obesity Hypoventilation Syndrome with CPAP use in medical history
• Contra-indication for nasogastric tube or inability to perform adequate PES measurements.
• Known diaphragm paralysis defined as elevated hemi-diaphragm on X-ray and evidence of paralysis during ultrasound (i.e. paradoxal diaphragm movement during sniffing)
• Known pregnancy or current breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Oxygen therapy	Conventional Oxygen Therapy	-
High Flow Nasal Oxygen	High Flow Nasal Oxygen	60L/minute. FiO2 according to clinical protocol. Temperature highest tolerated by patient, starting with 37 degrees Celcius.

Primary Outcome Measures

Name	Time	Method
delta Esophageal Pressure (ΔPES)	At 24 hours after extubation	The difference between groups in change in ΔPES in patients 24 hours post-extubation.

Secondary Outcome Measures

Name	Time	Method
Global Inhomogeneity index	At 2, 4 and 24 hours after extubation
EIT parameters	At 2, 4 and 24 hours after extubation	∆VARt, ∆EELIdependent, ∆EELInon-dependent compared to baseline (impedance on IMV).
ΔPES	At 2 and 4 hours post-extubation	The difference between groups in change in ΔPES after extubation
delta global End-expiratory lung impedance (∆EELIglobal)	At 2, 4 and 24 hours after extubation	Difference between the groups in change in mean ∆EELIglobal
Pressure-time product of Esophageal Pressure (PTPES)	At 2,4 and 24 hours after extubation	The difference between the groups in mean pressure-time product (PTPES) compared to baseline.

Trial Locations

Locations (2)

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

Maasstad Ziekenhuis; 🇳🇱 Rotterdam, Netherlands