Face-to-face Intubation in Morbidly Obese

NCT ID: NCT04959149

Last Updated: 2022-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2020-09-30

Brief Summary

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.

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.

Conditions

Intubation;Difficult; Obesity, Morbid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

face-to-face intubation

intubation approach from front of the patient

Group Type: EXPERIMENTAL

AirTraq videolaryngoscope

Intervention Type: DEVICE

intubation of morbidly obese patient using Airtraq videolaryngoscope

standard position intubation

intubation approach from behind the head of the patient

Group Type: ACTIVE_COMPARATOR

AirTraq videolaryngoscope

Intervention Type: DEVICE

intubation of morbidly obese patient using Airtraq videolaryngoscope

Interventions

AirTraq videolaryngoscope

intubation of morbidly obese patient using Airtraq videolaryngoscope

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Lodz

OTHER

Sponsor Role: lead

Responsible Party

Tomasz Gaszynski

professor of anaesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tomasz Gaszynski

Role: PRINCIPAL_INVESTIGATOR

Medical University of Lodz, Poland

Locations

Medical University of Lodz, Poland

Lodz, , Poland

Countries

Poland

References

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.

Reference Type: BACKGROUND

PMID: 26219732 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30031381 (View on PubMed)

Other Identifiers

RNN/62/20/KE

Identifier Type: -

Identifier Source: org_study_id