McGrath Videolaryngoscopy and Direct Laryngoscopy in Morbidly Obese Patients



Status:Recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 99
Updated:10/13/2018
Start Date:July 24, 2018
End Date:December 2019
Contact:Kurt Ruelzler, MD
Email:RUETZLK@ccf.org
Phone:216 636-0561

Use our guide to learn which trials are right for you!

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

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.

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)

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.
We found this trial at
1
site
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Phone: 216-444-9950
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials