Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03467048
Study type Interventional
Source The Cleveland Clinic
Contact
Status Completed
Phase N/A
Start date July 24, 2018
Completion date May 20, 2020

See also
  Status Clinical Trial Phase
Completed NCT03657927 - A Comparison of McGrath MAC Versus C-MAC Videolaryngoscopes in Morbidly Obese Patients N/A
Recruiting NCT04934826 - Comparison of the Absorption of Hydrolyzed or Intact Proteins in Morbid Obese Patients After the Roux Y Gastric Bypass N/A
Completed NCT03181347 - The Microbiology of Bariatric Surgery N/A
Completed NCT03886870 - Obesity, Lifestyle and Work Intervention N/A
Active, not recruiting NCT04433338 - The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery N/A
Completed NCT03553849 - Utilization of Very Low Calorie Diet in Obese General Surgery Patients N/A
Completed NCT05854875 - Diabetes Remission After RYGBP and RYGBP With Fundus Resection N/A
Not yet recruiting NCT03203161 - Registry on Obesity Surgery in Adolescents
Not yet recruiting NCT03601273 - Bariatric Embolization Trial for the Obese Nonsurgical Phase 1
Active, not recruiting NCT02545647 - Banded Versus Non-banded Roux-en-y Gastric Bypass N/A
Recruiting NCT02129296 - Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study Phase 1/Phase 2
Active, not recruiting NCT01564732 - Multicenter Prospective Randomized Controlled Trial of Plicated Laparoscopic Adjustable Gastric Banding N/A
Completed NCT02033265 - Ultrasound-Guided Axillary Brachial Plexus Block: Influence of Obesity
Completed NCT01963637 - Gastric Volumetry by Gastric Tomodensitometry With Gas N/A
Not yet recruiting NCT01652105 - Randomized Trial of Preoperative Diets Before Bariatric Surgery N/A
Terminated NCT01759550 - Prospective Case-Series of Ligasure Advance Pistol Grip and LigaSure Blunt Tip
Completed NCT01955993 - Fentanyl Metabolism in Obese Adolescents N/A
Completed NCT01149512 - Outcomes of the Adjustable Gastric Band in a Publicly Funded Obesity Program N/A
Recruiting NCT01685177 - Single Anastomosis Duodeno-Ileal Bypass vs Standard Duodenal Switch as a Second Step After Sleeve Gastrectomy in the Super-Morbid Obese Patient N/A
Completed NCT00624624 - Follow-up of Serum Androgen Profile After Bariatric Surgery in Men With Obesity Related Hypogonadotropic Hypogonadism N/A