Pre-AeRATE: Pre- and Apnoeic Oxygenation for RSI in ED
Study Details
Study Description
Brief Summary
Critically ill patients may need support for breathing by means of intubation, which is placement of a breathing tube into the windpipe. Rapid sequence intubation (RSI) is a method commonly used and is performed by administering medications to induce coma and muscle paralysis, followed by intubation to allow the ventilator to provide oxygen into the lungs. This procedure may be filled with potential complications.
During RSI, the patient stops spontaneous breathing after medically induced muscle paralysis occurs. Adequate oxygenation before and during paralysis is crucial to increase the reserves and prolong the time that oxygen levels in the blood remain above 90%, called the safe apnoea period. If the oxygen reserves are insufficient, the blood oxygen level will drop and can lead to permanent brain damage or even death.
This study aims to explore if delivering high-flow humidified oxygen at 60L/min via the nostrils would be superior to current methods of mask ventilation at 15L/min and nasal cannula at 15L/min, before and during paralysis respectively. If successful, this new method would allow for a longer safe apnoeic period and increase the chances for doctors to perform intubation successfully without the blood oxygen dropping below 90%.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Maintaining adequate oxygenation during rapid sequence intubation (RSI) is imperative to prevent peri-intubation adverse events that can lead to increased duration of hospital and intensive care unit stay, or prolonged vegetative state requiring long-term institutionalisation.
Preliminary data from our emergency department (ED) airway registry revealed that 15% of patients experienced desaturation during intubation despite employing current best practices during RSI. In this multicentre randomised controlled trial in the ED, we aim to test the hypothesis that use of humidified high flow oxygenation via nasal cannula (HFNC) at 60L/min maintains higher oxygen saturation compared with current usual care using non-rebreather mask for preoxygenation and provides superior apnoeic oxygenation compared to the typical practice of 15L/min via standard nasal cannula.
The main goal of the study would be to improve on the lowest oxygen saturation during intubation, and thereby increase the safe apnoeic time during RSI. We plan to enrol adult patients who require rapid sequence intubation due to medical, surgical or traumatic conditions in the EDs of National University Hospital and Ng Teng Fong General Hospital.
Eligible patients will undergo block randomisation at equal ratio into 2 possible treatment combinations of pre-oxygenation and apnoeic oxygenation. The primary endpoint will be the lowest oxygen saturation achieved from time of administration of paralytic agent until quantitative end-tidal carbon dioxide is detected for the first intubation attempt.
Higher failure rates for intubation in unfasted patients in the ED compared to fasted patients in elective settings increase the risk of aspiration if re-oxygenation is required with bag-valve-mask ventilation. Prolongation of safe apnoea time through maintenance of oxygen saturation above 90% using HFNC oxygenation during RSI could potentially change current clinical practice, improve standard of care and translate to better outcomes for patients.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention High-flow nasal cannula oxygenation at 60L/min for pre-oxygenation and apnoeic oxygenation |
Device: High-flow nasal cannulae (HFNC) oxygenation
Delivery of 60L/min of supplemental oxygen for pre-oxygenation and apnoeic oxygenation during rapid sequence intubation using the AIRVO™ 2 Humidifier with Integrated Flow Generator (Fisher & Paykel Healthcare, Auckland, New Zealand)
Other Names:
|
| Active Comparator: Control Pre-oxygenation using non-rebreather mask and apnoeic oxygenation via nasal cannulae at 15L/min |
Device: Non-rebreather mask and standard nasal cannula
Pre-oxygenation using non-rebreather mask and apnoeic oxygenation via nasal cannulae at 15L/min
|
Outcome Measures
Primary Outcome Measures
- Lowest SpO2 achieved during first intubation attempt [From time of administration of paralytic agent until quantitative ETCO2 is detected post-intubation up to 45 minutes]
Lowest SpO2 achieved during first intubation attempt which is defined as first attempt to insert endotracheal tube into oropharynx
Secondary Outcome Measures
- Number of attempts at intubation [Number of attempts required until successful intubation up to 45 minutes or termination of procedure, whichever is earlier]
Number of attempts until successful intubation as indicated by detection of quantitative ETCO2
- Safe apnoea time during intubation [From start of paralysis to time when SpO2 drops to less than 90% up to 45 minutes]
Duration of apnoea where SpO2 remains ≥ 90%
- Incidence of SpO2 < 90% [From start of paralysis to successful intubation up to 45 minutes]
Incidence of SpO2 < 90% during apnoea
- Peri-intubation adverse events [From induction to 15 minutes after intubation]
Peri-intubation adverse events defined as hypotension, hypertension, tachycardia, bradycardia, regurgitation, aspiration, cardiac arrhythmia, cardiac arrest during RSI, oropharynx or dental trauma
- Length of time to successful intubation [From induction until successful intubation as confirmed by detection of quantitative ETCO2 up to 45 minutes]
Time taken from induction to successful intubation attempt
Eligibility Criteria
Criteria
Inclusion Criteria:
- Adult patients aged 21 years and above, who require RSI due to medical, surgical and traumatic conditions, in the Emergency Departments of NUH and Ng Teng Fong General Hospital (NTFGH)
Exclusion Criteria:
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Patients with "do-not-resuscitate" orders
-
Crash, awake or delayed sequence intubations
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Patients requiring non-invasive positive pressure ventilation
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Cardiac arrest
-
Clinical suspicion or confirmed diagnosis of base of skull fractures or severe facial trauma that precludes nasal cannula placement
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Vulnerable patient populations (e.g. pregnant women, prisoners)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National University Hospital | Singapore | Singapore |
Sponsors and Collaborators
- National University Hospital, Singapore
- Ng Teng Fong General Hospital
- Singapore Clinical Research Institute
Investigators
- Principal Investigator: Mui Teng Chua, MBBS, MPH, National University Hospital, Singapore
Study Documents (Full-Text)
More Information
Publications
None provided.- CNIG17may007