Effect of HFNO Therapy on Respiratory Effort After Extubation

Respiratory Failure Clinical Trial

— T-REX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05652699
• Other study ID #: NL80844.078.22
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Erasmus Medical Center
• Contact: Matthijs Janssen, MD
• Phone: +31107035142
• Email: m.l.janssen[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, Lung Ultrasound (LUS) score, dyspnea score, and respiratory and sputum parameters between patients undergoing different post-extubation oxygenation regimens.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• 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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam
Netherlands	Maasstad Ziekenhuis	Rotterdam

Sponsors (3)

Lead Sponsor	Collaborator
Henrik Endeman	Franciscus Gasthuis, Maasstad Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	EIT parameters	?VARt, ?EELIdependent, ?EELInon-dependent compared to baseline (impedance on IMV).	At 2, 4 and 24 hours after extubation
Other	Global Inhomogeneity index		At 2, 4 and 24 hours after extubation
Other	non-invasive positive pressure ventilation (NIPPV)	Treatment escalation	Within 7 days post-extubation
Other	Continuous positive airway pressure (CPAP)	Treatment escalation	Within 7 days post-extubation
Other	invasive mechanical ventilation (IMV).	Treatment escalation	Within 7 days post-extubation
Other	Survival rate	Survival rates	Within 7 days post-extubation
Primary	mean delta Esophageal Pressure (?PES)	The difference between groups in change in mean ?PES in patients 24 hours post-extubation.	At 24 hours after extubation
Secondary	mean ?PES	The difference between groups in change in mean ?PES after extubation	At 2 and 4 hours post-extubation
Secondary	delta global End-expiratory lung impedance (?EELIglobal)	Difference between the groups in change in mean ?EELIglobal	At 2, 4 and 24 hours after extubation
Secondary	Pressure-time product of Esophageal Pressure (PTPES)	The difference between the groups in mean pressure-time product (PTPES) compared to baseline.	At 2,4 and 24 hours after extubation
Secondary	Lung ultrasound (LUS) score	Difference between groups in LUS scores	At 2 and 24 hours after extubation.
Secondary	Dyspnea score	Difference in dyspnea sensation between the groups, measured with Visual Analog Scale (VAS, ranging from 0 = No dyspnea until 10 = maximum dyspnea).	At 2 and 24 hours after extubation
Secondary	Sputum	Difference in sputum aspect and sputum clearance between the study groups, assessed with a 5-point likert scale.	At 2 and 24 hours after extubation