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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53601
Enrollment
54
Registered
2022-08-29
Start date
2023-01-19
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory failure respiratory support

Interventions

Before extubation, patients are randomized to receive conventional oxygen (reference group) or HFNO as oxygenation regimen after extubation. Both groups will undergo several minimally invasive measu

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)