New Position for Endotracheal Intubation of Obese Patients

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Anesthesia
• Intervention / Treatment: Other: Modified ramped position; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11432
    • Ahmed Mohamed Hasanin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified ramped position group; In this group, induction of anesthesia will be performed in the modified ramped position.	Other: 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.
Active Comparator: Ramped position group; In this group, induction of anesthesia will be performed in the ordinary ramped position.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for endotracheal intubation	Defined as the time measured in seconds from handling the laryngoscope till confirmation of correct position of endotracheal tube	5 minutes after induction of general anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of laryngoscopy	Time measured in seconds from handling the laryngoscope till insertion of the whole blade length into the oral cavity	5 minutes after induction of general anesthesia
Oxygen saturation	Oxygen saturation measured by pulse oximeter as percentage.	5 minutes after induction of general anesthesia
End-tidal carbon dioxide	End-tidal carbon dioxide measured in mmhg by capnography	5 minutes after induction of general anesthesia
Heart rate	Heart rate measured as number of heart beats per minute	5 minutes after induction of general anesthesia
Incidence of difficult laryngoscopy	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"	5 minutes after induction of general anesthesia
Incidence of difficult mask ventilation	The incidence of difficult mask ventilation defined as the need for high force or the need for additional assistant for maintenance of adequate ventilation	5 minutes after induction of general anesthesia

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Ashraf Rady, Professor, Head of department of anesthesia, Cairo University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2018
• Primary Completion (Actual): February 15, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 5, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 22, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: N-73-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No