High Flow Nasal Oxygen Therapy re-evaluated from a conceptual point of view: Effect on Respiratory Effort and Lung Aeration after Extubatio

• Conditions: respiratory failure; respiratory support; 10038716

• Registration Number: NL-OMON53601
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 54

Inclusion Criteria

- Aged >= 18 years
- Receiving invasive mechanical ventilation >48 hours for any cause
- Scheduled for extubation as per local clinical guideline
- Provided informed consent

Exclusion Criteria

- Any clinical situation preventing appropriate execution of study procedures,
such as;
o Severe agitated delirium
o Do not reintubate order
- The presence of a tracheostomy
- Respiratory acidosis, defined as a pH <7.32 with hypercapnia (PCO2 >6.5 kPa /
PCO2 > 50 mmHg) during or after SBT
- Any feature that prohibits HFNO-initiation
o Recent facial upper-airway surgery
o Anatomic abnormalities that preclude appropriate fitting of HFNO
cannula
o Current exacerbation of obstructive pulmonary disease
- Obstructive/central Sleep Apnoea Syndrome or Obesity Hypoventilation Syndrome
in medical history
- Contra-indication for nasogastric tube or inability to perform adequate PES
measurements, e.g.:
o Recent esophageal surgery
o Prior esophagectomy
o Known presence of esophageal varices
o Severe bleeding disorders
- Known diaphragm paralysis defined as elevated hemi-diaphragm on X-ray or
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: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome is the difference in change in lung respiratory muscle effort<br /><br>(mean &Delta;PES) at 24 hours post-extubation between the study groups. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are differences in changes in respiratory effort at 2 and<br /><br>4 hours post-extubation, difference in change in lung aeration (mean &Delta;EELI),<br /><br>differences in tidal volume, Lung Ultrasound (LUS) score, dyspnea score, and<br /><br>respiratory and sputum parameters between patients undergoing different<br /><br>post-extubation oxygenation regimens.</p><br>