Face-to-face Intubation in Morbidly Obese

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04959149
• Other study ID #: RNN/62/20/KE
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: June 2022
• Source: Medical University of Lodz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 30, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intubation;Difficult
• Obesity, Morbid

Intervention

Device:
• AirTraq videolaryngoscope
intubation of morbidly obese patient using Airtraq videolaryngoscope

Locations

Country	Name	City	State
Poland	Medical University of Lodz, Poland	Lódz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lodz

Country where clinical trial is conducted

Poland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	time of intubation	time of intubation measured from grabbing the device to confirming the correct placement using EtCO2	during the intervention/procedure
Secondary	effectiveness	effectiveness as number of correct placement of endotracheal tube in the trachea of the patient	during the intervention/procedure