New Position for Endotracheal Intubation of Obese Patients

NCT ID: NCT03732976

Last Updated: 2019-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-10
• Study Completion Date: 2019-03-01

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.

Conditions

Obesity; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Modified ramped position group

In this group, induction of anesthesia will be performed in the modified ramped position.

Group Type: EXPERIMENTAL

Modified ramped position

Intervention Type: 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 group

In this group, induction of anesthesia will be performed in the ordinary ramped position.

Group Type: ACTIVE_COMPARATOR

Ramped position

Intervention Type: 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

Interventions

Modified ramped position

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.

Intervention Type: OTHER

Ramped position

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Hasanin

Assistant professor of anesthesia and critical care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashraf Rady, Professor

Role: STUDY_DIRECTOR

Head of department of anesthesia, Cairo University, Egypt

Locations

Ahmed Mohamed Hasanin

Cairo, , Egypt

Countries

Egypt

Other Identifiers

N-73-2018

Identifier Type: -

Identifier Source: org_study_id