Clinical trial NCT03640442: Modified Ramped Position for Intubation of Obese Females.
Official title: Modified Ramped Position for Intubation of Obese Females: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of difficult laryngoscopy
timeFrame: 5 minutes after induction of general anesthesia
Secondary outcomes:
measure: Time of laryngoscopy
timeFrame: 5 minutes after induction of general anesthesia
measure: Time till complete visualization of the vocal cords
timeFrame: 5 minutes after induction of general anesthesia
measure: Oxygen saturation
timeFrame: 5 minutes after induction of general anesthesia
measure: End-tidal carbon dioxide
timeFrame: 5 minutes after induction of general anesthesia
measure: Heart rate
timeFrame: 5 minutes after induction of general anesthesia
measure: incidence of difficult mask ventilation
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Assistant professor of anesthesia
name: Ahmed Hasanin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.