Trial Outcomes & Findings for McGrath Videolaryngoscopy and Direct Laryngoscopy in Morbidly Obese Patients (NCT NCT03467048)
NCT ID: NCT03467048
Last Updated: 2020-07-14
Results Overview
Glottis visualization is evaluated according to the modified Cormack and Lehane classification. It is a grading system from 1 to 4: 1 = full view of glottis; 2a = partial view of glottis;2b = only posterior extremity of glottis seen or only arytenoid cartilages; 3 = only epiglottis seen, none of glottis seen; 4 = neither glottis nor epiglottis seen.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
130 participants
Primary outcome timeframe
At intubation
Results posted on
2020-07-14
Participant Flow
Participant milestones
| Measure |
McGrath Videolaryngoscopy
Endotracheal intubation using McGrath videolaryngoscopy in an appropriate size (usually blade size 3 or 4)
McGrath videolaryngoscopy: Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.
The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords.
|
Direct Laryngoscopy
Endotracheal intubation using direct laryngoscopy with an appropriately sized Macintosh blade (usually size 3 or 4)
Direct laryngoscopy: Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.
The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
64
|
|
Overall Study
COMPLETED
|
66
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
McGrath Videolaryngoscopy and Direct Laryngoscopy in Morbidly Obese Patients
Baseline characteristics by cohort
| Measure |
McGrath Videolaryngoscopy
n=66 Participants
Endotracheal intubation using McGrath videolaryngoscopy in an appropriate size (usually blade size 3 or 4)
McGrath videolaryngoscopy: Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.
The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords.
|
Direct Laryngoscopy
n=63 Participants
Endotracheal intubation using direct laryngoscopy with an appropriately sized Macintosh blade (usually size 3 or 4)
Direct laryngoscopy: Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.
The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 14 • n=99 Participants
|
47 years
STANDARD_DEVIATION 13 • n=107 Participants
|
49 years
STANDARD_DEVIATION 14 • n=206 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
54 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=99 Participants
|
63 participants
n=107 Participants
|
129 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At intubationGlottis visualization is evaluated according to the modified Cormack and Lehane classification. It is a grading system from 1 to 4: 1 = full view of glottis; 2a = partial view of glottis;2b = only posterior extremity of glottis seen or only arytenoid cartilages; 3 = only epiglottis seen, none of glottis seen; 4 = neither glottis nor epiglottis seen.
Outcome measures
| Measure |
McGrath Videolaryngoscopy
n=66 Participants
Endotracheal intubation using McGrath videolaryngoscopy in an appropriate size (usually blade size 3 or 4)
McGrath videolaryngoscopy: Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.
The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords.
|
Direct Laryngoscopy
n=63 Participants
Endotracheal intubation using direct laryngoscopy with an appropriately sized Macintosh blade (usually size 3 or 4)
Direct laryngoscopy: Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.
The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords.
|
|---|---|---|
|
Classification of Glottis Visualization
1
|
45 Participants
|
23 Participants
|
|
Classification of Glottis Visualization
2a
|
11 Participants
|
16 Participants
|
|
Classification of Glottis Visualization
2b
|
7 Participants
|
14 Participants
|
|
Classification of Glottis Visualization
3
|
3 Participants
|
6 Participants
|
|
Classification of Glottis Visualization
4
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: intubationintubation failure
Outcome measures
| Measure |
McGrath Videolaryngoscopy
n=66 Participants
Endotracheal intubation using McGrath videolaryngoscopy in an appropriate size (usually blade size 3 or 4)
McGrath videolaryngoscopy: Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.
The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords.
|
Direct Laryngoscopy
n=63 Participants
Endotracheal intubation using direct laryngoscopy with an appropriately sized Macintosh blade (usually size 3 or 4)
Direct laryngoscopy: Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.
The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords.
|
|---|---|---|
|
Number of Intubation Failure
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: intubationPopulation: excluded intubation failure
Outcome measures
| Measure |
McGrath Videolaryngoscopy
n=64 Participants
Endotracheal intubation using McGrath videolaryngoscopy in an appropriate size (usually blade size 3 or 4)
McGrath videolaryngoscopy: Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.
The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords.
|
Direct Laryngoscopy
n=58 Participants
Endotracheal intubation using direct laryngoscopy with an appropriately sized Macintosh blade (usually size 3 or 4)
Direct laryngoscopy: Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.
The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords.
|
|---|---|---|
|
Number of Intubation Attempts Among Those With Successful Intubation
1 intubation attempt
|
61 Participants
|
56 Participants
|
|
Number of Intubation Attempts Among Those With Successful Intubation
2 intubation attempts
|
3 Participants
|
2 Participants
|
Adverse Events
McGrath Videolaryngoscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Direct Laryngoscopy
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place