Effect of HFNO Therapy on Respiratory Effort After Extubation

NCT ID: NCT05652699

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-10-22

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.

Conditions

Respiratory Failure; Post Extubation Acute Respiratory Failure Requiring Reintubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High Flow Nasal Oxygen

60L/minute. FiO2 according to clinical protocol. Temperature highest tolerated by patient, starting with 37 degrees Celcius.

Group Type: ACTIVE_COMPARATOR

High Flow Nasal Oxygen

Intervention Type: OTHER

Flow 60L/minute. FiO2 according to clinical protocol. Temperature highest tolerated by patient, starting with 37 degrees Celsius.

Conventional Oxygen therapy

Group Type: ACTIVE_COMPARATOR

Conventional Oxygen Therapy

Intervention Type: OTHER

Nasal Cannula, Venturi Mask or Non-rebreathing mask, according to local clinical protocols

Interventions

High Flow Nasal Oxygen

Flow 60L/minute. FiO2 according to clinical protocol. Temperature highest tolerated by patient, starting with 37 degrees Celsius.

Intervention Type: OTHER

Conventional Oxygen Therapy

Nasal Cannula, Venturi Mask or Non-rebreathing mask, according to local clinical protocols

Intervention Type: OTHER

Other Intervention Names

High Flow Nasal Cannula; Nasal High Flow Therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Franciscus Gasthuis

OTHER

Sponsor Role: collaborator

Maasstad Hospital

OTHER

Sponsor Role: collaborator

Henrik Endeman

OTHER

Sponsor Role: lead

Responsible Party

Henrik Endeman

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Erasmus MC

Rotterdam, , Netherlands

Maasstad Ziekenhuis

Rotterdam, , Netherlands

Countries

Netherlands

Other Identifiers

NL80844.078.22

Identifier Type: -

Identifier Source: org_study_id