NCT03732976

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

November 10, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

November 5, 2018

Last Update Submit

November 22, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time for endotracheal intubation

    Defined as the time measured in seconds from handling the laryngoscope till confirmation of correct position of endotracheal tube

    5 minutes after induction of general anesthesia

Secondary Outcomes (6)

  • Time of laryngoscopy

    5 minutes after induction of general anesthesia

  • Incidence of difficult laryngoscopy

    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

  • +1 more secondary outcomes

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

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

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

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Mohamed Hasanin

Cairo, 11432, Egypt

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ashraf Rady, Professor

    Head of department of anesthesia, Cairo University, Egypt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of anesthesia and critical care

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 7, 2018

Study Start

November 10, 2018

Primary Completion

February 15, 2019

Study Completion

March 1, 2019

Last Updated

November 25, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations