NCT02366182

Brief Summary

Failed intubation and ventilation in obstetrics remains one of the most common causes of death directly related to anesthesia. The reported incidence of failed intubation in obstetrics is 1:300, which is significantly higher than that in the non-obstetric population. A clinical screening test with high sensitivity and specificity for prediction of difficult airway may help reduce morbidity and mortality from general anesthesia. Few studies have identified increased neck circumference as the best single predictor of problematic intubation. However the cutoff point of this test for identifying patients at high risk of difficult intubation is not clear. The aim of this study is to determine the optimal cutoff point, which validates prediction of difficult ventilation and/or intubation for obstetric patients. Preoperative airway assessment will be done including neck circumference. Intraoperative difficult ventilation and/or intubation will be recorded. Optimal cutoff point of neck circumference will be calculated by Receiver Operating characteristics (ROC) curve.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 3, 2015

Status Verified

July 1, 2015

Enrollment Period

5 months

First QC Date

January 18, 2015

Last Update Submit

July 2, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difficult intubation

    Difficult intubation defined as Intubation difficulty scale (IDS) \>5

    5 minutes

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients scheduled for cesarean section under general anesthesia

You may qualify if:

  • Patients scheduled for cesarean section under general anesthesia

You may not qualify if:

  • Patients with upper airway pathology
  • Patients with cervical spine abnormality
  • Emergency cesarean section
  • Known cases of difficult intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corniche Hospital

Abu Dhabi, 3788, United Arab Emirates

Location

Related Publications (1)

  • Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.

    PMID: 9416711BACKGROUND

Study Officials

  • Waleed Riad, MD

    Corniche Hospital

    PRINCIPAL INVESTIGATOR
  • Tarek Ansari, FFARCSI

    Corniche Hospital

    PRINCIPAL INVESTIGATOR
  • Nanda Shetty, MD

    Corniche Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2015

First Posted

February 19, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 3, 2015

Record last verified: 2015-07

Locations