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Completed

NCT Number: NCT04959149

Face-to-face Intubation in Morbidly Obese

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.

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Key information

Conditions

Intubation;Difficult Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Lodz, Poland

Lodz, 90-153, Poland

About this study

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.

  • 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.
  • Patients will be pre-oxygenated for 5 min. with 100% oxygen using facemask.
  • 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.
  • After mask ventilation possibility is confirmed, rocuronium in a dose of 0,6 mg.kg-1 will be given.
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

AirTraq videolaryngoscope

Device

intubation of morbidly obese patient using Airtraq videolaryngoscope

Primary outcomes

  1. time of intubation

    Time frame: during the intervention/procedure

    time of intubation measured from grabbing the device to confirming the correct placement using EtCO2

Secondary outcomes

  1. effectiveness

    Time frame: during the intervention/procedure

    effectiveness as number of correct placement of endotracheal tube in the trachea of the patient

Other outcomes

  1. complications

    Time frame: immediately after the intervention/procedure

    complications defined as soft tissue injuries ex lips or mucosa of oral cavity injury, sore throat after extubation, desaturations below 92%

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 13, 2021
Registry last updated
Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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