N/A
N=180
Fibre-optic Guided Tracheal Intubation Through SADs
Intubation; Difficult or Failed · Laryngeal Masks · Airway Management
Bottom Line
View on ClinicalTrials.gov: NCT03118596 ↗Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Total Intubation Time to Perform Fibreoptic Intubation — 54.3; 52.0 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- I-gel (Device); LMA Protector (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Intubation Time to Perform Fibreoptic Intubation |
54.3; 52.0 | — |
| SECONDARY SAD Insertion Time |
19.4; 25.4 | — |
| SECONDARY Number of Attempts at the SAD Placement |
— | — |
| SECONDARY Number of Participants With Ease of Placement of the SAD |
86; 37; 6; 44; 0; 5 | — |
| SECONDARY Number of Participants With First and Second Attempt at Tracheal Intubation |
90; 84; 2; 2 | — |
| SECONDARY Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD |
71; 72; 20; 14; 1; 0 | — |
| SECONDARY Time to Carinal View |
23.4; 21.9 | — |
| SECONDARY Number of Participants With Type of Airway Maneuvers Performed During Tracheal Intubation, |
38; 23; 54; 63 | — |
Summary
The study aims to establish which of the two second generation Supraglottic Airway Devices, the I-gel or the the laryngeal ask airway (LMA) Protector, is best suited to be used as a conduit to fibreoptic bronchoscope assisted tracheal intubation. The primary outcome of this will be the time to complete the tracheal intubation.
Eligibility Criteria
Inclusion Criteria
- All patients aged above 18, presenting for elective surgical procedure, where a supraglottic airway device can be used and left in place throughout the duration of surgery and requiring tracheal intubation
Exclusion Criteria
- Patients who are do not wish to take part
- Patients with class II obesity (BMI >40)
- Patients below 18 years of age
- American Society of Anaesthesiologists (ASA 3, 4 and 5)
- Patients with mouth opening of less than 3 cm
- Patients deemed to require awake intubation
- Surgery involving head and neck region
- Surgery requiring prone position
Data sourced from ClinicalTrials.gov (NCT03118596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.