Face-to-face Intubation in Morbidly Obese

A Comparison of Face-to-face Endotracheal Intubation and Typical Intubation With Airtraq Video Laryngoscope in Bariatric Patients: a Randomised Controlled Trail

Introduction : In a typical endotracheal intubation, the patient is in the supine position, with the anesthetist standing behind his head and with adequate access to the head and neck of the patient. However, there are several situations, where traditional intubation is very difficult or even impossible. In immobilised trauma victims, with limited access to the head, suspected cervical spine injury or in sitting positioned patient an intubation performed by a person standing in front of a patient might be the only chance of airway management. Moreover, in case of general anesthesia in bariatric patients, face-to-face (inverse) method is increasingly being considered due to upper body elevation position, recommended in this group of patients.

This was a parallel randomised controlled trial in patients scheduled for planned sleeve gastrectomy in Barlicki University Hospital, Lodz, Poland. Randomization and allocation to trial group were carried out by drawing envelopes by independent observer before a procedure. Randomized and recruited participants were 76 adults (typical intubation n= 36, face-to-face intubation n=40). Main outcome was a time of intubation using Airtraq video laryngoscope measured by independent assistant.

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid; Intubation;Difficult
• Intervention / Treatment: Device: AirTraq videolaryngoscope

Detailed Description

Aim : The aim of the study is to evaluate the effectiveness and safety of face-to-face intubation in airway management.

Methods : Patients admitted to hospital for elective sleeve gastrectomy procedure will be included in the study protocol. Before induction of anaesthesia the draw of the method will be held. The choice of method of intubation (inverse or typical) will be random.

1. All patients will be positioned with the elevation of the upper body about 30 degrees. The standard anesthesia monitoring involves electrocardiogram, pulsoxymetry, non-invasive blood pressure and end-tidal carbon dioxide.
2. Patients will be pre-oxygenated for 5 min. with 100% oxygen using facemask.
3. The induction of general anesthesia will be performed by the intravenous administration of 1-2 µg.kg-1 of fentanyl and 2-2,5 mg.kg-1 propofol.
4. After mask ventilation possibility is confirmed, rocuronium in a dose of 0,6 mg.kg-1 will be given.
5. After obtaining an optimal muscle relaxation (90 s.) patient will be intubated. In face-to-face method an anesthetist is standing in front of a patient. In typical intubation an anesthetist is standing behind the patient's head.
6. In case of prolonged face-to-face intubation (>120 s) or 2 unsuccessful attempts, patients are supposed to be intubated in a traditional way with the same video laryngoscope.
7. General anesthesia will be continued with desflurane and a mixture of the oxygen and air, volume-controlled ventilation parameters will be adjusted to age and ideal body weight.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Łódź, Poland, 90-153
    • Medical University of Lodz, Poland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. BMI > 40 kg.m-2
2. Patients qualified for planned sleeve gastrectomy.
3. Patients of I and II class of ASA scale.
4. Patients without history of difficult intubation.

Exclusion Criteria:

1. Patients in life threatening states.
2. Patients of III, IV, V and VI class of ASA scale.
3. History of difficult intubation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: face-to-face intubation; intubation approach from front of the patient	Device: AirTraq videolaryngoscope; intubation of morbidly obese patient using Airtraq videolaryngoscope
Active Comparator: standard position intubation; intubation approach from behind the head of the patient	Device: AirTraq videolaryngoscope; intubation of morbidly obese patient using Airtraq videolaryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time of intubation	time of intubation measured from grabbing the device to confirming the correct placement using EtCO2	during the intervention/procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effectiveness	effectiveness as number of correct placement of endotracheal tube in the trachea of the patient	during the intervention/procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications	complications defined as soft tissue injuries ex lips or mucosa of oral cavity injury, sore throat after extubation, desaturations below 92%	immediately after the intervention/procedure

Collaborators and Investigators

• Sponsor: Medical University of Lodz
• Investigators: Principal Investigator: Tomasz Gaszynski, Medical University of Lodz, Poland

Publications and helpful links

General Publications

• Arslan ZI, Alparslan V, Ozdal P, Toker K, Solak M. Face-to-face tracheal intubation in adult patients: a comparison of the Airtraq, Glidescope and Fastrach devices. J Anesth. 2015 Dec;29(6):893-8. doi: 10.1007/s00540-015-2052-6. Epub 2015 Jul 29.
• Jeong H, Chae M, Seo H, Yi JW, Kang JM, Lee BJ. Face-to-face intubation using a lightwand in a patient with severe thoracolumbar kyphosis: a case report. BMC Anesthesiol. 2018 Jul 21;18(1):92. doi: 10.1186/s12871-018-0556-y.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: obesity; intubation; videolaryngoscope
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: RNN/62/20/KE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No