Pre- and Apnoeic Oxygenation for RSI in ED

NCT03396094 | Completed DMC

• 1 other identifier: CNIG17may007
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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%.

Conditions

Intubation; Oxygen Inhalation Therapy

Keywords

high flow oxygenation, rapid sequence intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of attempts at intubation

  Number of attempts required until successful intubation up to 45 minutes or termination of procedure, whichever is earlier

• Safe apnoea time during intubation

  From start of paralysis to time when SpO2 drops to less than 90% up to 45 minutes

• Incidence of SpO2 < 90%

  From start of paralysis to successful intubation up to 45 minutes

• Peri-intubation adverse events

  From induction to 15 minutes after intubation

• Length of time to successful intubation

  From induction until successful intubation as confirmed by detection of quantitative ETCO2 up to 45 minutes

Study Arms (2)

Intervention

EXPERIMENTAL

High-flow nasal cannula oxygenation at 60L/min for pre-oxygenation and apnoeic oxygenation

Device: High-flow nasal cannulae (HFNC) oxygenation

Control

ACTIVE COMPARATOR

Pre-oxygenation using non-rebreather mask and apnoeic oxygenation via nasal cannulae at 15L/min

Device: Non-rebreather mask and standard nasal cannula

Interventions

High-flow nasal cannulae (HFNC) oxygenation DEVICE

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)

Also known as: AIRVO™ 2 Humidifier with Integrated Flow Generator

Intervention

Non-rebreather mask and standard nasal cannula DEVICE

Pre-oxygenation using non-rebreather mask and apnoeic oxygenation via nasal cannulae at 15L/min

Control

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Ng Teng Fong General Hospital: collaborator
• Singapore Clinical Research Institute: collaborator

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

Related Publications (1)

• Chua MT, Khan FA, Ng WM, Lu Q, Low MJW, Yau YW, Punyadasa A, Kuan WS. Pre- and Apnoeic high flow oxygenation for RApid sequence intubation in The Emergency department (Pre-AeRATE): study protocol for a multicentre, randomised controlled trial. Trials. 2019 Apr 4;20(1):195. doi: 10.1186/s13063-019-3305-8.

  PMID: 30947740 DERIVED

Study Officials

• Mui Teng Chua, MBBS, MPH

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 1, 2018
• First Posted: January 10, 2018
• Study Start: May 7, 2018
• Primary Completion: January 1, 2020
• Study Completion: July 31, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)