Intubation Clinical Trial
— Pre-AeRATEOfficial title:
Pre- and Apnoeic High Flow Oxygenation for RApid Sequence Intubation in The Emergency Department (Pre-AeRATE): a Multicentre Randomised Controlled Trial
NCT number | NCT03396094 |
Other study ID # | CNIG17may007 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 7, 2018 |
Est. completion date | July 31, 2020 |
Verified date | March 2021 |
Source | National University Hospital, Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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%.
Status | Completed |
Enrollment | 192 |
Est. completion date | July 31, 2020 |
Est. primary completion date | January 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 99 Years |
Eligibility | 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: - Patients with "do-not-resuscitate" orders - Crash, awake or delayed sequence intubations - Patients requiring non-invasive positive pressure ventilation - Cardiac arrest - Clinical suspicion or confirmed diagnosis of base of skull fractures or severe facial trauma that precludes nasal cannula placement - Vulnerable patient populations (e.g. pregnant women, prisoners) |
Country | Name | City | State |
---|---|---|---|
Singapore | National University Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University Hospital, Singapore | Ng Teng Fong General Hospital, Singapore Clinical Research Institute |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lowest SpO2 achieved during first intubation attempt | Lowest SpO2 achieved during first intubation attempt which is defined as first attempt to insert endotracheal tube into oropharynx | From time of administration of paralytic agent until quantitative ETCO2 is detected post-intubation up to 45 minutes | |
Secondary | Number of attempts at intubation | Number of attempts until successful intubation as indicated by detection of quantitative ETCO2 | Number of attempts required until successful intubation up to 45 minutes or termination of procedure, whichever is earlier | |
Secondary | Safe apnoea time during intubation | Duration of apnoea where SpO2 remains = 90% | From start of paralysis to time when SpO2 drops to less than 90% up to 45 minutes | |
Secondary | Incidence of SpO2 < 90% | Incidence of SpO2 < 90% during apnoea | From start of paralysis to successful intubation up to 45 minutes | |
Secondary | Peri-intubation adverse events | Peri-intubation adverse events defined as hypotension, hypertension, tachycardia, bradycardia, regurgitation, aspiration, cardiac arrhythmia, cardiac arrest during RSI, oropharynx or dental trauma | From induction to 15 minutes after intubation | |
Secondary | Length of time to successful intubation | Time taken from induction to successful intubation attempt | From induction until successful intubation as confirmed by detection of quantitative ETCO2 up to 45 minutes |
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