Status:
COMPLETED
To Compare Videolaryngoscope Against Direct Laryngoscope for Intubation When Powered Air Purifying Respirator is Worn
Lead Sponsor:
Singapore General Hospital
Collaborating Sponsors:
Duke-NUS Graduate Medical School
Conditions:
Coronavirus Infection
Ventilatory Failure
Eligibility:
All Genders
21-99 years
Phase:
NA
Brief Summary
Various guidelines for endotracheal intubation (insertion of breathing tube for mechanical ventilation) of Coronavirus Disease 2019 (COVID-19) patients recommend the use of videolaryngoscope (medical ...
Detailed Description
Background: 17% of patients with Coronavirus Disease 2019 (COVID-19) may require endotracheal intubation for mechanical ventilation due to respiratory failure. Various guidelines for endotracheal in...
Eligibility Criteria
Inclusion
- Patients who attend the Pre-operative Evaluation Clinic (PEC) in Singapore General Hospital (SGH) for pre-anesthesia assessment will be screened by a study team member for recruitment if they meet the inclusion criteria.
- Patients will be undergoing routine pre-anesthesia assessment (including review of medical conditions and airway anatomy) by the anesthetists in the PEC prior to their planned elective surgeries. During their routine pre-anesthesia assessment, they will also be assessed by a study team member to confirm if they meet the eligibility criteria. If they are eligible for enrollment, a qualified practitioner will take informed consent.
- We will also recruit 10 anesthetists from the Division to perform the intubations. The 10 anaesthetists will have to self-report experience in both the use of McGrath videolaryngoscope (VL) and direct laryngoscope (DL) for intubation (at least 20 successful intubations with McGrath VL or DL).
- Inclusion Criteria for patients:
- 21 years old and above
- Not pregnant
- ASA physical status I, II and III
- BMI less than 35kg/m2
- Elective surgical operations requiring general anesthesia and endotracheal intubation
- Able to give own informed consent
- No features of difficult airway which has to consist all of the following:
- Class I and II on the modified Mallampati classification
- Thyromental distance of 6.5cm and above
- Mouth opening of 3.5cm and above
- Sterno-mental distance of 12.5cm and above
- Inclusion Criteria for Anesthetists:
- Qualified anesthetists (associate consultants and above)
- Experience with both the use of McGrath VL and DL for intubation (at least 20 successful intubations using McGrath VL)
- Willing to perform intubation with PAPR donned and using either the McGrath VL or DL
- Exclusion Criteria for patients:
- Below 21 years old
- Pregnancy
- ASA status IV and above
- Poorly-controlled cardiorespiratory conditions (such as poorly-controlled asthma with Asthma Control Test ≤ 19, chronic obstructive pulmonary disease GOLD 2 and above, exertional angina, coronary artery disease with active symptoms, heart failure with New York Heart Association Class III and above)
- Body Mass Index ≥ 35 kg/m2
- Emergency operation
- Unable to give own consent
- Any feature of difficult airway which is
- Class III and IV on the Modified Mallampati Classification
- Thyromental distance less than 6.5cm
- Mouth opening less than 3.5cm
- Sterno-mental distance less than 12.5cm
- History of difficult intubation
- Unstable cervical spine
- Exclusion criteria for anesthetists:
- Non-specialist anesthetist
- Inexperience with both the use of McGrath VL and DL for intubation (less than 20 successful intubations using McGrath VL)
- Unwilling to perform intubation with PAPR donned using either the McGrath VL or DL
Exclusion
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04424953
Start Date
June 1 2020
End Date
September 25 2020
Last Update
March 17 2021
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore