Modified Ramped Position for Intubation of Obese Females.

Not Applicable

Completed

• Conditions: Obesity; Anesthesia
• Interventions: Other: Modified ramped position; Other: Ramped position

• Registration Number: NCT03640442
• Lead Sponsor: Cairo University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-08-18
• Study First Submitted QC: 2018-08-18
• Study First Posted: 2018-08-21
• Study Start: 2018-09-09
• Primary Completion: 2019-04-20
• Study Completion: 2019-04-25
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-20
• Last Update Posted: 2019-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• female patients
• obese (with body mass index above 30 kg per squared meter)
• Scheduled for surgery under general anesthesia.

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Exclusion Criteria

• Patients with scars in the face or neck.
• Edentulous patients.
• Patients with airway masses.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified ramped position group	Modified ramped position	In this group, induction of anesthesia will be performed in the modified ramped position.
Ramped position group	Ramped position	In this group, induction of anesthesia will be performed in the ordinary ramped position.

Primary Outcome Measures

Name	Time	Method
Incidence of difficult laryngoscopy	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"

Secondary Outcome Measures

Name	Time	Method
Time till complete visualization of the vocal cords	5 minutes after induction of general anesthesia	Defined as the time measured in seconds from handling the laryngoscope till visualization of the vocal cords.
Oxygen saturation	5 minutes after induction of general anesthesia	Oxygen saturation measured by pulse oximeter as percentage.
End-tidal carbon dioxide	5 minutes after induction of general anesthesia	End-tidal carbon dioxide measured in mmhg by capnography
Heart rate	5 minutes after induction of general anesthesia	Heart rate measured as number of heart beats per minute
Time of laryngoscopy	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
incidence of difficult mask ventilation	5 minutes	The incidence of difficult mask ventilation defined as the need for high force or the need for additional assistant for maintenance of adequate ventilation

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt