Trial Outcomes & Findings for Comparison of Glottic Views and Intubation Times in the Supine and 25 Degree Back-up Positions (NCT NCT02934347)
NCT ID: NCT02934347
Last Updated: 2017-05-11
Results Overview
The best glottic view obtained during laryngoscopy was assessed using the Cormack and Lehane classification by the anaesthetist performing the laryngoscopy. The Cormack and Lehane classifies glottic views as follows: Grade 1: Most of the glottis is visible, Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen., Grade 3: Only the epiglottis is visible, Grade 4: No laryngeal structures are visible.
Recruitment status
COMPLETED
Target enrollment
781 participants
Primary outcome timeframe
The view of the glottis was measured once while the patient was being intubated
Results posted on
2017-05-11
Participant Flow
Participant milestones
| Measure |
Supine
A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
|
Back-up
A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
|
|---|---|---|
|
Overall Study
STARTED
|
374
|
407
|
|
Overall Study
COMPLETED
|
374
|
407
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One patient's gender was not recorded
Baseline characteristics by cohort
| Measure |
Supine
n=374 Participants
A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
|
Back-up
n=407 Participants
A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
|
Total
n=781 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 17.6 • n=374 Participants
|
55.8 years
STANDARD_DEVIATION 16.9 • n=407 Participants
|
56.6 years
STANDARD_DEVIATION 17.2 • n=781 Participants
|
|
Sex: Female, Male
Female
|
188 Participants
n=374 Participants • One patient's gender was not recorded
|
218 Participants
n=406 Participants • One patient's gender was not recorded
|
406 Participants
n=780 Participants • One patient's gender was not recorded
|
|
Sex: Female, Male
Male
|
186 Participants
n=374 Participants • One patient's gender was not recorded
|
188 Participants
n=406 Participants • One patient's gender was not recorded
|
374 Participants
n=780 Participants • One patient's gender was not recorded
|
|
Region of Enrollment
United Kingdom
|
374 participants
n=374 Participants
|
407 participants
n=407 Participants
|
781 participants
n=781 Participants
|
|
BMI
|
28.5 Kg/m^2
STANDARD_DEVIATION 5.5 • n=374 Participants
|
28 Kg/m^2
STANDARD_DEVIATION 5.8 • n=407 Participants
|
28.2 Kg/m^2
STANDARD_DEVIATION 5.6 • n=781 Participants
|
|
Type of surgery
General
|
248 participants
n=374 Participants
|
233 participants
n=407 Participants
|
481 participants
n=781 Participants
|
|
Type of surgery
Gynaecology
|
44 participants
n=374 Participants
|
24 participants
n=407 Participants
|
68 participants
n=781 Participants
|
|
Type of surgery
Urology
|
29 participants
n=374 Participants
|
19 participants
n=407 Participants
|
48 participants
n=781 Participants
|
|
Type of surgery
ENT
|
24 participants
n=374 Participants
|
43 participants
n=407 Participants
|
67 participants
n=781 Participants
|
|
Type of surgery
Ophthalmology
|
0 participants
n=374 Participants
|
1 participants
n=407 Participants
|
1 participants
n=781 Participants
|
|
Type of surgery
Orthopaedics
|
12 participants
n=374 Participants
|
3 participants
n=407 Participants
|
15 participants
n=781 Participants
|
|
Type of surgery
Facio-Maxillary
|
10 participants
n=374 Participants
|
62 participants
n=407 Participants
|
72 participants
n=781 Participants
|
|
Type of surgery
Trauma
|
4 participants
n=374 Participants
|
18 participants
n=407 Participants
|
22 participants
n=781 Participants
|
|
Type of surgery
Vascular
|
2 participants
n=374 Participants
|
4 participants
n=407 Participants
|
6 participants
n=781 Participants
|
|
Type of surgery
Not recorded
|
1 participants
n=374 Participants
|
0 participants
n=407 Participants
|
1 participants
n=781 Participants
|
|
Grade of intubating anaesthetist
Senior
|
272 participants
n=374 Participants
|
264 participants
n=407 Participants
|
536 participants
n=781 Participants
|
|
Grade of intubating anaesthetist
Not recorded
|
1 participants
n=374 Participants
|
0 participants
n=407 Participants
|
1 participants
n=781 Participants
|
|
Grade of intubating anaesthetist
Trainee
|
101 participants
n=374 Participants
|
143 participants
n=407 Participants
|
244 participants
n=781 Participants
|
PRIMARY outcome
Timeframe: The view of the glottis was measured once while the patient was being intubatedPopulation: Adult patients who required intubation as part of their routine anaesthesia
The best glottic view obtained during laryngoscopy was assessed using the Cormack and Lehane classification by the anaesthetist performing the laryngoscopy. The Cormack and Lehane classifies glottic views as follows: Grade 1: Most of the glottis is visible, Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen., Grade 3: Only the epiglottis is visible, Grade 4: No laryngeal structures are visible.
Outcome measures
| Measure |
Supine
n=374 Participants
A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
|
Back-up
n=407 Participants
A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
|
|---|---|---|
|
The Best Glottic View Obtained During Laryngoscopy
Cormack and Lehane Grade 1
|
186 participants
|
228 participants
|
|
The Best Glottic View Obtained During Laryngoscopy
Cormack and Lehane Grade 2
|
163 participants
|
151 participants
|
|
The Best Glottic View Obtained During Laryngoscopy
Cormack and Lehane Grade 3
|
23 participants
|
24 participants
|
|
The Best Glottic View Obtained During Laryngoscopy
Cormack and Lehane Grade 4
|
2 participants
|
2 participants
|
|
The Best Glottic View Obtained During Laryngoscopy
Not recorded
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Once at intubationPopulation: Adult patients who required intubation as part of their routine anaesthesia
The number of attempts at both laryngoscopy and tracheal intubation were recorded
Outcome measures
| Measure |
Supine
n=374 Participants
A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
|
Back-up
n=407 Participants
A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
|
|---|---|---|
|
The Number of Attempts at Both Laryngoscopy and Tracheal Intubation
>2 Intubation attempts
|
0 participants
|
1 participants
|
|
The Number of Attempts at Both Laryngoscopy and Tracheal Intubation
1 Laryngoscopy attempt
|
340 participants
|
371 participants
|
|
The Number of Attempts at Both Laryngoscopy and Tracheal Intubation
2 Laryngoscopy attempts
|
25 participants
|
27 participants
|
|
The Number of Attempts at Both Laryngoscopy and Tracheal Intubation
>2 Laryngoscopy attempts
|
5 participants
|
3 participants
|
|
The Number of Attempts at Both Laryngoscopy and Tracheal Intubation
Laryngoscopy attempts Not recorded
|
4 participants
|
6 participants
|
|
The Number of Attempts at Both Laryngoscopy and Tracheal Intubation
1 Intubation attempt
|
346 participants
|
378 participants
|
|
The Number of Attempts at Both Laryngoscopy and Tracheal Intubation
2 Intubation attempts
|
22 participants
|
18 participants
|
|
The Number of Attempts at Both Laryngoscopy and Tracheal Intubation
Intubation attempts Not recorded
|
6 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Once at intubationPopulation: Adult patients who required intubation as part of their routine anaesthesia
The use of ancillary equipment (e.g. bougie, alternative laryngoscope blades) and manoeuvres (e.g. laryngeal manipulation) were recorded but applied at the intubating anaesthetist's discretion
Outcome measures
| Measure |
Supine
n=374 Participants
A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
|
Back-up
n=407 Participants
A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
|
|---|---|---|
|
The Use of Ancillary Equipment
Ancillary equipment: Bougie
|
58 participants
|
61 participants
|
|
The Use of Ancillary Equipment
Other Ancillary equipment
|
3 participants
|
4 participants
|
|
The Use of Ancillary Equipment
Ancillary manoeuvre: Cricoid
|
19 participants
|
2 participants
|
|
The Use of Ancillary Equipment
Ancillary equipment: 'Not Used'
|
308 participants
|
341 participants
|
|
The Use of Ancillary Equipment
Ancillary equipment use not recorded
|
5 participants
|
1 participants
|
|
The Use of Ancillary Equipment
Ancillary manoeuvre: BURP
|
34 participants
|
25 participants
|
|
The Use of Ancillary Equipment
External laryngeal manipulation
|
39 participants
|
53 participants
|
|
The Use of Ancillary Equipment
Ancillary manoeuvres: 'Not Used'
|
277 participants
|
326 participants
|
|
The Use of Ancillary Equipment
Ancillary manoeuvres not recorded
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Once at intubationPopulation: Adult patients who required intubation as part of their routine anaesthesia
The time between the beginning of laryngoscopy and detection of carbon dioxide on the end-tidal carbon dioxide monitor after the successful placement of the tracheal tube was recorded
Outcome measures
| Measure |
Supine
n=374 Participants
A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
|
Back-up
n=407 Participants
A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
|
|---|---|---|
|
The Time Between the Beginning of Laryngoscopy and Detection of Carbon Dioxide on the End-tidal Carbon Dioxide Monitor
Senior
|
26 seconds
Interval 17.25 to 40.0
|
21 seconds
Interval 16.0 to 36.0
|
|
The Time Between the Beginning of Laryngoscopy and Detection of Carbon Dioxide on the End-tidal Carbon Dioxide Monitor
Trainee
|
30 seconds
Interval 22.0 to 47.5
|
27 seconds
Interval 18.75 to 42.0
|
|
The Time Between the Beginning of Laryngoscopy and Detection of Carbon Dioxide on the End-tidal Carbon Dioxide Monitor
Senior & Trainee combined
|
28 seconds
Interval 18.0 to 42.0
|
24 seconds
Interval 16.0 to 39.0
|
Adverse Events
Supine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Back-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Raj Reddy
Glan Clwyd Hospital, Betsi Cadwaladr University Health Board
Phone: 01745 583910
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place