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Pre- and Apnoeic Oxygenation for RSI in ED (Pre-AeRATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03396094
Recruitment Status : Active, not recruiting
First Posted : January 10, 2018
Last Update Posted : March 13, 2020
Sponsor:
Collaborators:
Ng Teng Fong General Hospital
Singapore Clinical Research Institute
Information provided by (Responsible Party):
National University Hospital, Singapore

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
Intubation Oxygen Inhalation Therapy Device: High-flow nasal cannulae (HFNC) oxygenation Device: Non-rebreather mask and standard nasal cannula Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study consists of 2 arms (intervention and control) of parallel design. The intervention arm will receive high flow nasal cannula (HFNC) oxygenation at 60L/min for pre- and apnoeic oxygenation while the control arm will receive pre-oxygenation via non-rebreather mask and apnoeic oxygenation via nasal cannulae at 15L/min.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pre- and Apnoeic High Flow Oxygenation for RApid Sequence Intubation in The Emergency Department (Pre-AeRATE): a Multicentre Randomised Controlled Trial
Actual Study Start Date : May 7, 2018
Actual Primary Completion Date : January 1, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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 Name: AIRVO™ 2 Humidifier with Integrated Flow Generator

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




Primary Outcome Measures :
  1. Lowest SpO2 achieved during first intubation attempt [ Time Frame: 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 :
  1. Number of attempts at intubation [ Time Frame: 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

  2. Safe apnoea time during intubation [ Time Frame: From start of paralysis to time when SpO2 drops to less than 90% up to 45 minutes ]
    Duration of apnoea where SpO2 remains ≥ 90%

  3. Incidence of SpO2 < 90% [ Time Frame: From start of paralysis to successful intubation up to 45 minutes ]
    Incidence of SpO2 < 90% during apnoea

  4. Peri-intubation adverse events [ Time Frame: 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

  5. Length of time to successful intubation [ Time Frame: From induction until successful intubation as confirmed by detection of quantitative ETCO2 up to 45 minutes ]
    Time taken from induction to successful intubation attempt



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396094


Locations
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Singapore
National University Hospital
Singapore, Singapore
Sponsors and Collaborators
National University Hospital, Singapore
Ng Teng Fong General Hospital
Singapore Clinical Research Institute
Investigators
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Principal Investigator: Mui Teng Chua, MBBS, MPH National University Hospital, Singapore
  Study Documents (Full-Text)

Documents provided by National University Hospital, Singapore:
Study Protocol  [PDF] December 29, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT03396094    
Other Study ID Numbers: CNIG17may007
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National University Hospital, Singapore:
high flow oxygenation, rapid sequence intubation
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes