Modified Ramped Position for Intubation of Obese Females.

Modified Ramped Position for Intubation of Obese Females: a Randomized Controlled Study

The aim of this work is to investigate the feasibility of using the modified a ramped position for intubation of obese females 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 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. Some commercially available pillows were introduced to facilitate laryngoscopy in obese patients such as: Troop elevation pillow and Rapid airway management positioner.

In addition to difficult laryngeal visualization, another problem commonly confronts anesthetists during intubation of obese females; that is impedance of laryngoscopy by large breasts. 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 in the presence of large breasts.

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 bring the breasts away from the laryngoscope. After successful introduction of the laryngoscope in the oral cavity, the head will be elevated using a head rest to achieve ordinary ramped position if laryngeal visualization was not adequate.

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): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 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: Double

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
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

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
Time till complete visualization of the vocal cords	Defined as the time measured in seconds from handling the laryngoscope till visualization of the vocal cords.	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 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

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Hasanin A, Tarek H, Mostafa MMA, Arafa A, Safina AG, Elsherbiny MH, Hosny O, Gado AA, Almenesey T, Hamden GA, Mahmoud M, Amin S. Modified-ramped position: a new position for intubation of obese females: a randomized controlled pilot study. BMC Anesthesiol. 2020 Jun 17;20(1):151. doi: 10.1186/s12871-020-01070-2.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2018
• Primary Completion (Actual): April 20, 2019
• Study Completion (Actual): April 25, 2019

Study Registration Dates

• First Submitted: August 18, 2018
• First Submitted That Met QC Criteria: August 18, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): June 24, 2019
• Last Update Submitted That Met QC Criteria: June 20, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: N-107-2018

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