New Position for Endotracheal Intubation of Obese Patients

• ClinicalTrials.gov Identifier: NCT03732976
• Recruitment Status: Completed
• First Posted: November 7, 2018
• Last Update Posted: November 25, 2019
• Sponsor: Cairo University
• Information provided by (Responsible Party): Ahmed Hasanin, Cairo University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Obesity; Anesthesia	Other: Modified ramped position; Other: Ramped position	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: New Position for Endotracheal Intubation of Obese Patients: a Randomized Controlled Comparison With the Ramped Position
• Actual Study Start Date: November 10, 2018
• Actual Primary Completion Date: February 15, 2019
• Actual Study Completion Date: March 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Egypt

Ahmed Mohamed Hasanin

Cairo, Egypt, 11432

Sponsors and Collaborators

Cairo University

Investigators

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

More Information

• Responsible Party: Ahmed Hasanin, Assistant professor of anesthesia and critical care, Cairo University
• ClinicalTrials.gov Identifier: NCT03732976
• Other Study ID Numbers: N-73-2018
• First Posted: November 7, 2018
• Last Update Posted: November 25, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No