Effect of HFNO Therapy on Respiratory Effort After Extubation

NCT05652699 | Completed DMC

• 1 other identifier: NL80844.078.22
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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

Keywords

High-flow oxygen; Intensive Care Unit; Extubation; Reintubation; Respiratory Effort; Aeration

Outcome Measures

Primary Outcomes (1)

• delta Esophageal Pressure (ΔPES)

  The difference between groups in change in ΔPES in patients 24 hours post-extubation.

  At 24 hours after extubation

Secondary Outcomes (5)

• ΔPES

  At 2 and 4 hours post-extubation

• delta global End-expiratory lung impedance (∆EELIglobal)

  At 2, 4 and 24 hours after extubation

• Pressure-time product of Esophageal Pressure (PTPES)

  At 2,4 and 24 hours after extubation

• EIT parameters

  At 2, 4 and 24 hours after extubation

• Global Inhomogeneity index

  At 2, 4 and 24 hours after extubation

Other Outcomes (6)

• non-invasive positive pressure ventilation (NIPPV)

  Within 7 days post-extubation

• Continuous positive airway pressure (CPAP)

  Within 7 days post-extubation

• invasive mechanical ventilation (IMV).

  Within 7 days post-extubation

Study Arms (2)

High Flow Nasal Oxygen

ACTIVE COMPARATOR

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

Other: High Flow Nasal Oxygen

Conventional Oxygen therapy

ACTIVE COMPARATOR

Other: Conventional Oxygen Therapy

Interventions

High Flow Nasal Oxygen OTHER

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

Also known as: High Flow Nasal Cannula, Nasal High Flow Therapy

High Flow Nasal Oxygen

Conventional Oxygen Therapy OTHER

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

Conventional Oxygen therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henrik Endeman: lead
• Franciscus Gasthuis: collaborator
• Maasstad Hospital: collaborator

Study Sites (2)

Erasmus MC

Rotterdam, 3015GD, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, 3079 DZ, Netherlands

Location

Related Publications (1)

• Janssen ML, Weller D, Wils EJ, Lupgens N, den Uil CA, Boer DP, Gommers DAMPJ, Heunks LMA, Jonkman AH, Endeman H. Physiological Effects of High-Flow Nasal Oxygen Compared With Conventional Oxygen Therapy: A Randomized Trial in Postextubation Patients. Crit Care Med. 2025 Dec 15. doi: 10.1097/CCM.0000000000006993. Online ahead of print.

  PMID: 41395998 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 15, 2022
• Study Start: October 1, 2022
• Primary Completion: October 22, 2024
• Study Completion: October 22, 2024
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

NL (2)