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McGrath Videolaryngoscopy and Direct Laryngoscopy in Morbidly Obese Patients

Comparison of McGrath Videolaryngoscopy and Direct Laryngoscopy for Intubation in Patients With Morbid Obesity in Non-cardiac Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03467048
Enrollment
130
Registered
2018-03-15
Start date
2018-07-24
Completion date
2020-05-20
Last updated
2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

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. 1. Age 2. Gender 3. Race 4. BMI 5. ASA status 6. Charlson score 7. Smoking status 8. Airway examination 1. History of obstructive sleep apnea (yes/no) 2. History of snoring (yes/no) 3. History of CPAP (yes/no) 4. History of difficult airway (yes/no) 5. Mobility of cervical spine (cm) 6. Mouth opening (cm) 7. Inter-incisor gap (cm) 8. Mandibular protrusion test 9. Thyro-mental distance (cm) 10. Sterno-mental distance (cm) 11. Neck circumference (cm) 12. Upper lip bite test (Class I, II, III) 13. Mallampati score (1/2/3/4) 14. Teeth status, Gap/missing teeth, Denture (n)

Interventions

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.

DEVICEDirect 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.

Sponsors

Medtronic
CollaboratorINDUSTRY
The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Classification of Glottis VisualizationAt 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.

Secondary

MeasureTime frameDescription
Number of Intubation Failureintubationintubation failure
Number of Intubation Attempts Among Those With Successful Intubationintubation

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
66
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.
63
Total129

Baseline characteristics

CharacteristicMcGrath VideolaryngoscopyDirect LaryngoscopyTotal
Age, Continuous51 years
STANDARD_DEVIATION 14
47 years
STANDARD_DEVIATION 13
49 years
STANDARD_DEVIATION 14
Race/Ethnicity, Customized
Race
African American
9 Participants9 Participants18 Participants
Race/Ethnicity, Customized
Race
Caucasian
54 Participants53 Participants107 Participants
Race/Ethnicity, Customized
Race
Hispanic
2 Participants1 Participants3 Participants
Race/Ethnicity, Customized
Race
Other
1 Participants0 Participants1 Participants
Region of Enrollment
United States
66 participants63 participants129 participants
Sex: Female, Male
Female
49 Participants46 Participants95 Participants
Sex: Female, Male
Male
17 Participants17 Participants34 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 660 / 63
other
Total, other adverse events
0 / 660 / 63
serious
Total, serious adverse events
0 / 660 / 63

Outcome results

Primary

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.

Time frame: At intubation

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
McGrath VideolaryngoscopyClassification of Glottis Visualization2a11 Participants
McGrath VideolaryngoscopyClassification of Glottis Visualization33 Participants
McGrath VideolaryngoscopyClassification of Glottis Visualization2b7 Participants
McGrath VideolaryngoscopyClassification of Glottis Visualization40 Participants
McGrath VideolaryngoscopyClassification of Glottis Visualization145 Participants
Direct LaryngoscopyClassification of Glottis Visualization44 Participants
Direct LaryngoscopyClassification of Glottis Visualization123 Participants
Direct LaryngoscopyClassification of Glottis Visualization2a16 Participants
Direct LaryngoscopyClassification of Glottis Visualization2b14 Participants
Direct LaryngoscopyClassification of Glottis Visualization36 Participants
p-value: <0.0195% CI: [2.22, 9.75]t-test, 1 sided
Secondary

Number of Intubation Attempts Among Those With Successful Intubation

Time frame: intubation

Population: excluded intubation failure

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
McGrath VideolaryngoscopyNumber of Intubation Attempts Among Those With Successful Intubation1 intubation attempt61 Participants
McGrath VideolaryngoscopyNumber of Intubation Attempts Among Those With Successful Intubation2 intubation attempts3 Participants
Direct LaryngoscopyNumber of Intubation Attempts Among Those With Successful Intubation1 intubation attempt56 Participants
Direct LaryngoscopyNumber of Intubation Attempts Among Those With Successful Intubation2 intubation attempts2 Participants
p-value: 0.4197.5% CI: [0.1, 7.77]t-test, 1 sided
Secondary

Number of Intubation Failure

intubation failure

Time frame: intubation

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
McGrath VideolaryngoscopyNumber of Intubation Failure2 Participants
Direct LaryngoscopyNumber of Intubation Failure5 Participants
p-value: 0.080.975% CI: [0.04, 2.28]t-test, 1 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026