Endotracheal Intubation in Bed up Head Elevation Position in Rapid Sequence Induction Clinical Trial
Official title:
Comparison of Bed up Head Elevated Position With Sniffing Position in Rapid Sequence Induction: a Randomised, Controlled, Non-inferiority Trial
This study is aimed to conduct a randomised controlled trial comparing endotracheal
intubation (ETI) in bed up head elevation BUHE position versus sniffing position in simulated
rapid sequence induction (RSI).
Objective is to determine if the time taken for intubation in the bed up head elevated
position is non-inferior to time taken for intubation in the sniffing position.
The hypotheses:
1. In patients undergoing rapid sequence induction in simulated emergency surgery under
general anaesthesia, direct laryngoscopy (DL) and ETI in the BUHE position is non
inferior to time required for DL and successful ETI in the sniffing position.
2. In patients undergoing rapid sequence induction in simulated emergency surgery under
general anaesthesia, direct laryngoscopy (DL) and ETI in the BUHE position improve POGO
score.
3. In patients undergoing rapid sequence induction in simulated emergency surgery under
general anaesthesia, direct laryngoscopy (DL) and ETI in the BUHE position reduces
airway related complications.
Terminology:
Direct laryngoscopy (DL) and Endotracheal intubation (ETI): Is a method of inserting a
breathing tube into the trachea (windpipe) once patient undergo general anaesthesia.
Bed up head elevation (BUHE): Bed up at 20-30 degree aiming alignment between the external
auditory meatus with sternal notch.
Sniffing position: Maintaining supine position with head elevation with head rest.
Rapid sequence induction (RSI): An established method of inducing anaesthesia in patients who
are at risk of aspiration of gastric contents into the lungs. It involves loss of
consciousness during cricoid pressure followed by intubation without face mask ventilation.
The aim is to intubate the trachea as quickly and as safely as possible.
POGO score: Percentage of glottic opening
Cricoid Pressure (CP): Maneuvre to prevent regurgitation of gastric contents during induction
of anaesthesia by temporary occlusion of the upper end of the esophagus by backward pressure
of cricoid cartilage against bodies of cervical vertebrae.
| Status | Recruiting |
| Enrollment | 54 |
| Est. completion date | June 30, 2019 |
| Est. primary completion date | June 30, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - All patients undergoing elective surgery under general anaesthesia from age 18 years old to 75 years old. Exclusion Criteria: - Patients with airway obstruction - Patients with contraindication to neck extension - BMI> 35kg/m2 - Patient with history of difficult airway from previous intubation history - Only single intubation will be included if patients had multiple surgery during their hospital stay - Patients with ischaemic heart disease, cerebrovascular diseases and respiratory disease |
| Country | Name | City | State |
|---|---|---|---|
| Malaysia | University Malaya Medical Centre | Kuala Lumpur | Wilayah Persekutuan Kuala Lumpur |
| Lead Sponsor | Collaborator |
|---|---|
| University of Malaya |
Malaysia,
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* Note: There are 37 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time in seconds measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave | Measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave | Intraoperatively , during induction of anaesthesia | |
| Secondary | Number of laryngoscopy and intubation attempt | Number of attempts taken by investigator to obtain successful endotracheal intubation in both arms | Intraoperatively , during induction of anaesthesia | |
| Secondary | Laryngeal exposure measured via POGO score | Percentage of glottic opening during laryngoscopy | Intraoperatively , during induction of anaesthesia | |
| Secondary | Occurrence of difficult intubation | Defined as =3 attempts at intubation | Intraoperatively , during induction of anaesthesia | |
| Secondary | Occurrence of hypoxia | Hypoxia defined as pulse oximetry reading less than 95 percents | Intraoperatively , during induction of anaesthesia | |
| Secondary | The use of any other airway adjunct or external laryngeal manipulation to assist in intubation | Change of blade size, bougie, magill forcep, video assisted laryngoscope,external laryngeal manipulation (Use of any airway adjunct is grouped as one) | Intraoperatively , during induction of anaesthesia | |
| Secondary | Occurrence of esophageal intubation | Unsuccessful intubation into esophagus | Intraoperatively , during induction of anaesthesia | |
| Secondary | Occurrence of airway trauma | broken tooth, bleeding or injury from oral cavity, tongue or lips, etc | Intraoperatively , during induction of anaesthesia |