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Completed

NCT Number: NCT03732976

New Position for Endotracheal Intubation of Obese Patients

The aim of this work is to investigate the feasibility of using the modified a ramped position for mask ventilation and endotracheal intubation of obese patients in comparison to the traditional ramped position

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Key information

Conditions

Obesity Anesthesia Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Mohamed Hasanin

Cairo, 11432, Egypt

About this study

Adequate conditions for endotracheal intubation and mask ventilation require appropriate positioning of head and neck. The sniffing position had been described as the most appropriate head position for endotracheal intubation. Sniffing position is achieved through two main components: flexion of the neck by 35° (achieved by head elevation) and extension of the head by 15° 2 to have the sternum at the same level of external auditory meatus 34. Sniffing position has the advantage of alignment of the three axes: oral, pharyngeal, and laryngeal axes for reaching the optimal laryngeal visualization.

In obese patients, it is recommended to put the patient in the ramped position (back-up position with the tragus of the ear is at the level of the suprasternal notch) in addition to the sniffing head-and-neck position.

In addition to difficult laryngeal visualization, another problem commonly confronts anesthetists during intubation of obese such as: 1- Impedance to complete mouth opening due to fatty face and neck. 2- Impedance of laryngoscopy by large breasts in females. This problem commonly hinders the intubation process and might lead to serious hypoxia. Most of the positions described in literature were concerned with facilitating laryngeal visualization. No position to the best of our knowledge was applied to aid the introduction of the laryngoscope.

The investigators hypothesized that using a special pillow to achieve a modified ramped position (by slight extension of the neck) at the beginning of the laryngoscopy would enhance mouth opening and bring the breasts away from the laryngoscope. After successful introduction of the laryngoscope in the oral cavity, the head could be manually elevated (if required) to achieve sniffing position.

The aim of this work is to investigate the feasibility of using the aforementioned modified ramped position for intubation of obese females in comparison to the traditional ramped position.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • female patients
  • obese (with body mass index above 30 kg per squared meter)
  • Scheduled for surgery under general anesthesia.

Exclusion criteria

  • Patients with scars in the face or neck.
  • Edentulous patients.
  • Patients with airway masses.

Treatment and study plan

Modified ramped position

Other

This position will be achieved using a special pillow. Shoulders will be elevated and neck will be extended to bring the breasts away from the laryngoscopy. The patient will be positioned so that the tip of the last spinous process (C7) will be at the edge of the pillow. The neck will be extended to the most possible range.

Ramped position

Other

This position will be achieved by elevation of the shoulders and the head elevation till achieving alignment of sternal notch and external auditory meatus

Primary outcomes

  1. Time for endotracheal intubation

    Time frame: 5 minutes after induction of general anesthesia

    Defined as the time measured in seconds from handling the laryngoscope till confirmation of correct position of endotracheal tube

Secondary outcomes

  1. Time of laryngoscopy

    Time frame: 5 minutes after induction of general anesthesia

    Time measured in seconds from handling the laryngoscope till insertion of the whole blade length into the oral cavity

  2. Incidence of difficult laryngoscopy

    Time frame: 5 minutes after induction of general anesthesia

    Defined as "failure to insert the laryngoscope in the oral cavity due to large breast with the need to reposition the patient to insert the laryngoscope"

  3. Oxygen saturation

    Time frame: 5 minutes after induction of general anesthesia

    Oxygen saturation measured by pulse oximeter as percentage.

  4. End-tidal carbon dioxide

    Time frame: 5 minutes after induction of general anesthesia

    End-tidal carbon dioxide measured in mmhg by capnography

  5. Heart rate

    Time frame: 5 minutes after induction of general anesthesia

    Heart rate measured as number of heart beats per minute

  6. Incidence of difficult mask ventilation

    Time frame: 5 minutes after induction of general anesthesia

    The incidence of difficult mask ventilation defined as the need for high force or the need for additional assistant for maintenance of adequate ventilation

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

New Position for Endotracheal Intubation of Obese Patients: a Randomized Controlled Comparison With the Ramped Position

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 7, 2018
Registry last updated
Nov 25, 2019

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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