Modified Ramped Position for Intubation of Obese Females.

NCT03640442 | Completed DMC

• 1 other identifier: N-107-2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Time of laryngoscopy

  5 minutes after induction of general anesthesia

• Time till complete visualization of the vocal cords

  5 minutes after induction of general anesthesia

• Oxygen saturation

  5 minutes after induction of general anesthesia

• End-tidal carbon dioxide

  5 minutes after induction of general anesthesia

• Heart rate

  5 minutes after induction of general anesthesia

Study Arms (2)

Modified ramped position group

EXPERIMENTAL

In this group, induction of anesthesia will be performed in the modified ramped position.

Other: Modified ramped position

Ramped position group

ACTIVE COMPARATOR

In this group, induction of anesthesia will be performed in the ordinary ramped position.

Other: Ramped position

Interventions

Modified ramped position OTHER

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.

Modified ramped position group

Ramped position OTHER

This position will be achieved by elevation of the shoulders and the head elevation till achieving alignment of sternal notch and external auditory meatus

Ramped position group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (1)

• 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.

  PMID: 32552691 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed Hasanin, Professor

  Assistant professor of anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 18, 2018
• First Posted: August 21, 2018
• Study Start: September 9, 2018
• Primary Completion: April 20, 2019
• Study Completion: April 25, 2019
• Last Updated: June 24, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)