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| Name | Class |
|---|---|
| Franciscus Gasthuis | OTHER |
| Maasstad Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Flow Nasal Oxygen | Active Comparator | 60L/minute. FiO2 according to clinical protocol. Temperature highest tolerated by patient, starting with 37 degrees Celcius. |
|
| Conventional Oxygen therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Flow Nasal Oxygen | Other | Flow 60L/minute. FiO2 according to clinical protocol. Temperature highest tolerated by patient, starting with 37 degrees Celsius. |
|
| Measure | Description | Time Frame |
|---|---|---|
| delta Esophageal Pressure (ΔPES) | The difference between groups in change in ΔPES in patients 24 hours post-extubation. | At 24 hours after extubation |
| Measure | Description | Time Frame |
|---|---|---|
| ΔPES | The difference between groups in change in ΔPES after extubation | At 2 and 4 hours post-extubation |
| delta global End-expiratory lung impedance (∆EELIglobal) | Difference between the groups in change in mean ∆EELIglobal |
| Measure | Description | Time Frame |
|---|---|---|
| non-invasive positive pressure ventilation (NIPPV) | Treatment escalation | Within 7 days post-extubation |
| Continuous positive airway pressure (CPAP) | Treatment escalation |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Rotterdam | 3015GD | Netherlands | |||
| Maasstad Ziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41395998 | Derived | 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. 2026 Apr 1;54(4):836-847. doi: 10.1097/CCM.0000000000006993. Epub 2025 Dec 15. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| Conventional Oxygen Therapy | Other | Nasal Cannula, Venturi Mask or Non-rebreathing mask, according to local clinical protocols |
|
| At 2, 4 and 24 hours after extubation |
| 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 |
| EIT parameters | ∆VARt, ∆EELIdependent, ∆EELInon-dependent compared to baseline (impedance on IMV). | At 2, 4 and 24 hours after extubation |
| Global Inhomogeneity index | At 2, 4 and 24 hours after extubation |
| Within 7 days post-extubation |
| invasive mechanical ventilation (IMV). | Treatment escalation | Within 7 days post-extubation |
| Survival rate | Survival rates | Within 7 days post-extubation |
| 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 |
| 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 |
| Rotterdam |
| 3079 DZ |
| Netherlands |