Clinical trial NCT05652699: Effect of HFNO Therapy on Respiratory Effort After Extubation
Official title: High Flow Nasal Oxygen Therapy Re-evaluated from a Conceptual Point of View: Effect on Respiratory Effort and Lung Aeration After Extubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Post Extubation Acute Respiratory Failure Requiring Reintubation
Keywords: High-flow oxygen
Intensive Care Unit
Extubation
Reintubation
Respiratory Effort
Aeration
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Franciscus Gasthuis
name: Maasstad Hospital
First posted: 2022-12-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: delta Esophageal Pressure (ΔPES)
timeFrame: At 24 hours after extubation
Secondary outcomes:
measure: ΔPES
timeFrame: At 2 and 4 hours post-extubation
measure: delta global End-expiratory lung impedance (∆EELIglobal)
timeFrame: At 2, 4 and 24 hours after extubation
measure: Pressure-time product of Esophageal Pressure (PTPES)
timeFrame: At 2,4 and 24 hours after extubation
measure: EIT parameters
timeFrame: At 2, 4 and 24 hours after extubation
measure: Global Inhomogeneity index
timeFrame: At 2, 4 and 24 hours after extubation
Other outcomes:
measure: non-invasive positive pressure ventilation (NIPPV)
timeFrame: Within 7 days post-extubation
measure: Continuous positive airway pressure (CPAP)
timeFrame: Within 7 days post-extubation
measure: invasive mechanical ventilation (IMV).
timeFrame: Within 7 days post-extubation
measure: Survival rate
timeFrame: Within 7 days post-extubation
measure: Sputum
timeFrame: At 2 and 24 hours after extubation
measure: Dyspnea score
timeFrame: At 2 and 24 hours after extubation
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
Study officials:
References: