Respiratory Failure, Post Extubation Acute Respiratory Failure Requiring Reintubation
Conditions
Keywords
High-flow oxygen, Intensive Care Unit, Extubation, Reintubation, Respiratory Effort, Aeration
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.
Interventions
Flow 60L/minute. FiO2 according to clinical protocol. Temperature highest tolerated by patient, starting with 37 degrees Celsius.
Nasal Cannula, Venturi Mask or Non-rebreathing mask, according to local clinical protocols
Sponsors
Franciscus Gasthuis
Maasstad Hospital
Henrik Endeman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| delta Esophageal Pressure (ΔPES) | At 24 hours after extubation | The difference between groups in change in ΔPES in patients 24 hours post-extubation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ΔPES | At 2 and 4 hours post-extubation | The difference between groups in change in ΔPES after extubation |
| delta global End-expiratory lung impedance (∆EELIglobal) | At 2, 4 and 24 hours after extubation | Difference between the groups in change in mean ∆EELIglobal |
| Pressure-time product of Esophageal Pressure (PTPES) | At 2,4 and 24 hours after extubation | The difference between the groups in mean pressure-time product (PTPES) compared to baseline. |
| EIT parameters | At 2, 4 and 24 hours after extubation | ∆VARt, ∆EELIdependent, ∆EELInon-dependent compared to baseline (impedance on IMV). |
| Global Inhomogeneity index | At 2, 4 and 24 hours after extubation | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| non-invasive positive pressure ventilation (NIPPV) | Within 7 days post-extubation | Treatment escalation |
| Continuous positive airway pressure (CPAP) | Within 7 days post-extubation | Treatment escalation |
| invasive mechanical ventilation (IMV). | Within 7 days post-extubation | Treatment escalation |
| Survival rate | Within 7 days post-extubation | Survival rates |
| Sputum | At 2 and 24 hours after extubation | Difference in sputum aspect and sputum clearance between the study groups, assessed with a 5-point likert scale. |
| Dyspnea score | At 2 and 24 hours after extubation | Difference in dyspnea sensation between the groups, measured with Visual Analog Scale (VAS, ranging from 0 = No dyspnea until 10 = maximum dyspnea). |
Countries
Netherlands
Outcome results
None listed