McGrath Videolaryngoscopy and Direct Laryngoscopy in Morbidly Obese Patients
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
McGrath videolaryngoscopy
Direct laryngoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity
Eligibility Criteria
Inclusion Criteria:
- Elective surgery requiring oral endotracheal intubation for general anesthesia;
- Anticipated extubation in the operating room;
- American Society of Anesthesiologists (ASA) physical status 1-3;
- Age between 18 and 99 years;
- Body Mass index ≥ 40 kg/m2.
Exclusion Criteria:
- Refusal of participation by attending anesthesiologist;
- Indicated rapid sequence induction for any reason including, but not limited to high risk of aspiration
- Indicated fiberoptic awake intubation.
Sites / Locations
- Cleveland Clinic Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
McGrath videolaryngoscopy
Direct laryngoscopy
Arm Description
Endotracheal intubation using McGrath videolaryngoscopy in an appropriate size (usually blade size 3 or 4)
Endotracheal intubation using direct laryngoscopy with an appropriately sized Macintosh blade (usually size 3 or 4)
Outcomes
Primary Outcome Measures
Classification of Glottis Visualization
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.
Secondary Outcome Measures
Number of Intubation Failure
intubation failure
Number of Intubation Attempts Among Those With Successful Intubation
Full Information
NCT ID
NCT03467048
First Posted
March 9, 2018
Last Updated
June 29, 2020
Sponsor
The Cleveland Clinic
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT03467048
Brief Title
McGrath Videolaryngoscopy and Direct Laryngoscopy in Morbidly Obese Patients
Official Title
Comparison of McGrath Videolaryngoscopy and Direct Laryngoscopy for Intubation in Patients With Morbid Obesity in Non-cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 24, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
May 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
Medtronic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Our goal is to compare conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for endotracheal intubation in very morbidly obese patients undergoing non-cardiac surgery. Specifically, we propose to test the primary hypotheses that videolaryngoscopy improves visualization of the vocal cords, defined with modified Cormack and Lehane classification, compared to direct laryngoscopy.
Detailed Description
In the preoperative period, patient's airway data will be recorded by a research coordinator or anesthesia provider (Table 1). Patients will be positioned supine and in a standardized ramped position on the OR table. Patients will be pre-medicated with midazolam 0-2 mg IV, as clinically appropriate. All patients will be pre-oxygenated until the fraction of expired oxygen exceeds 80%. General anesthesia will be induced as preferred by the attending anesthesiologist, usually with a combination of lidocaine 1 mg/kg, propofol 2-5 mg/kg, fentanyl 1-3 µg/kg, and rocuronium 0.6-1.2 mg/kg or succinylcholine 1.5 mg/kg.
Manual bag-mask ventilation will be initiated, with no restriction on the use of oral airways, nasal airways, laryngeal masks. Complete muscle relaxation will be confirmed by absence of palpable twitches in response to supra-maximal train-of-four stimulation of the ulnar nerve at the wrist. After confirming adequate bag mask manual ventilation, patients will be randomized 1:1, stratified for BMI >50 kg/m2, to:
Direct laryngoscopy using an appropriately sized Macintosh blade (usually size 3 or 4);
McGrath videolaryngoscopy in an appropriate size (usually blade size 3 or 4). Randomization will be based on computer-generated codes accessed from the Redcap system shortly before anesthetic induction. Allocation will thus be concealed until the last possible minute.
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.
If initial intubation attempts fails, the endotracheal tube will be removed and manual bag mask ventilation will resume. Minor adjustments of patient's position and/or tube stylette are allowed as clinically appropriate. Up to three intubation attempts will be made as necessary. Further airway management will follow clinical assessment of the anesthesiologist. Additionally, throughout the procedure, the anesthesiologist could terminate the study participation.
Once intubation is achieved, the endotracheal tube will be connected to the anesthesia circuit. Mechanical ventilation with O2 and air will be adjusted to maintain end-tidal PCO2 between 32 and 35 mmHg as clinically necessary. Maintenance of general anesthesia will be provided, as clinically indicated.
At the end of the surgical procedure, patients will be extubated and transferred to the post anesthesia care unit (PACU). Patients will then be assessed for postoperative complications 2 hours following extubation, either in the PACU or surgical ward.
Measurements Table 1. Demographic and morphometric characteristics will be collected from electronic medical records.
Age
Gender
Race
BMI
ASA status
Charlson score
Smoking status
Airway examination
History of obstructive sleep apnea (yes/no)
History of snoring (yes/no)
History of CPAP (yes/no)
History of difficult airway (yes/no)
Mobility of cervical spine (cm)
Mouth opening (cm)
Inter-incisor gap (cm)
Mandibular protrusion test
Thyro-mental distance (cm)
Sterno-mental distance (cm)
Neck circumference (cm)
Upper lip bite test (Class I, II, III)
Mallampati score (1/2/3/4)
Teeth status, Gap/missing teeth, Denture (n)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
McGrath videolaryngoscopy
Arm Type
Experimental
Arm Description
Endotracheal intubation using McGrath videolaryngoscopy in an appropriate size (usually blade size 3 or 4)
Arm Title
Direct laryngoscopy
Arm Type
Active Comparator
Arm Description
Endotracheal intubation using direct laryngoscopy with an appropriately sized Macintosh blade (usually size 3 or 4)
Intervention Type
Device
Intervention Name(s)
McGrath videolaryngoscopy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Direct laryngoscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Classification of Glottis Visualization
Description
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.
Time Frame
At intubation
Secondary Outcome Measure Information:
Title
Number of Intubation Failure
Description
intubation failure
Time Frame
intubation
Title
Number of Intubation Attempts Among Those With Successful Intubation
Time Frame
intubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective surgery requiring oral endotracheal intubation for general anesthesia;
Anticipated extubation in the operating room;
American Society of Anesthesiologists (ASA) physical status 1-3;
Age between 18 and 99 years;
Body Mass index ≥ 40 kg/m2.
Exclusion Criteria:
Refusal of participation by attending anesthesiologist;
Indicated rapid sequence induction for any reason including, but not limited to high risk of aspiration
Indicated fiberoptic awake intubation.
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32175948
Citation
Ruetzler K, Rivas E, Cohen B, Mosteller L, Martin A, Keebler A, Maheshwari K, Steckner K, Wang M, Praveen C, Khanna S, Makarova N, Sessler DI, Turan A. McGrath Video Laryngoscope Versus Macintosh Direct Laryngoscopy for Intubation of Morbidly Obese Patients: A Randomized Trial. Anesth Analg. 2020 Aug;131(2):586-593. doi: 10.1213/ANE.0000000000004747.
Results Reference
derived
Learn more about this trial
McGrath Videolaryngoscopy and Direct Laryngoscopy in Morbidly Obese Patients
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