Clinical trial NCT04959149: Face-to-face Intubation in Morbidly Obese
Official title: A Comparison of Face-to-face Endotracheal Intubation and Typical Intubation With Airtraq Video Laryngoscope in Bariatric Patients: a Randomised Controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation;Difficult
Obesity, Morbid
Keywords: obesity
intubation
videolaryngoscope
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: time of intubation
timeFrame: during the intervention/procedure
Secondary outcomes:
measure: effectiveness
timeFrame: during the intervention/procedure
Other outcomes:
measure: complications
timeFrame: immediately after the intervention/procedure
Locations:
city: Łódź
country: Poland
facility: Medical University of Lodz, Poland
Study officials:
affiliation: Medical University of Lodz, Poland
name: Tomasz Gaszynski
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.