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Pre- and Apnoeic Oxygenation for RSI in ED

NCT03396094 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2021-03-03

No results posted yet for this study

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

Interventions

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)

DEVICE

Non-rebreather mask and standard nasal cannula

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

Sponsors & Collaborators

  • Ng Teng Fong General Hospital

    collaborator OTHER

  • Singapore Clinical Research Institute

    collaborator OTHER

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Mui Teng Chua, MBBS, MPH · National University Hospital, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-07
Primary Completion
2020-01-01
Completion
2020-07-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03396094 on ClinicalTrials.gov