Clinical trial NCT03732976: New Position for Endotracheal Intubation of Obese Patients
Official title: New Position for Endotracheal Intubation of Obese Patients: a Randomized Controlled Comparison With the Ramped Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time for endotracheal intubation
timeFrame: 5 minutes after induction of general anesthesia
Secondary outcomes:
measure: Time of laryngoscopy
timeFrame: 5 minutes after induction of general anesthesia
measure: Incidence of difficult laryngoscopy
timeFrame: 5 minutes after induction of general anesthesia
measure: Oxygen saturation
timeFrame: 5 minutes after induction of general anesthesia
measure: End-tidal carbon dioxide
timeFrame: 5 minutes after induction of general anesthesia
measure: Heart rate
timeFrame: 5 minutes after induction of general anesthesia
measure: Incidence of difficult mask ventilation
timeFrame: 5 minutes after induction of general anesthesia
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Mohamed Hasanin
Study officials:
affiliation: Head of department of anesthesia, Cairo University, Egypt
name: Ashraf Rady, Professor
role: STUDY_DIRECTOR
References: