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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04959149
Enrollment
76
Registered
2021-07-13
Start date
2020-03-01
Completion date
2020-09-30
Last updated
2022-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation;Difficult, Obesity, Morbid

Keywords

obesity, intubation, videolaryngoscope

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.

Interventions

DEVICEAirTraq videolaryngoscope

intubation of morbidly obese patient using Airtraq videolaryngoscope

Sponsors

Medical University of Lodz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
time of intubationduring the intervention/proceduretime of intubation measured from grabbing the device to confirming the correct placement using EtCO2

Secondary

MeasureTime frameDescription
effectivenessduring the intervention/procedureeffectiveness as number of correct placement of endotracheal tube in the trachea of the patient

Other

MeasureTime frameDescription
complicationsimmediately after the intervention/procedurecomplications defined as soft tissue injuries ex lips or mucosa of oral cavity injury, sore throat after extubation, desaturations below 92%

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026