NCT02589015

Brief Summary

The aim of this study is to determine the correlation of neck circumference with difficult mask ventilation and laryngoscopy in morbidly obese patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 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

March 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 11, 2016

Status Verified

February 1, 2016

Enrollment Period

9 months

First QC Date

August 20, 2015

Last Update Submit

February 10, 2016

Conditions

Keywords

morbid obesityneck circumferencedifficult mask ventilationdifficult laryngoscopy

Outcome Measures

Primary Outcomes (2)

  • Correlation of difficult laryngoscopy with neck circumference

    Cormack Lehane scores III and IV were defined as difficult laryngoscopy.

    Cormack Lehane score was assessed during laryngoscopy

  • Correlation of difficult mask ventilation with neck circumference

    Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate. V3 and V4 was defined as difficult mask ventilation.

    Ventilation difficulty scale was assessed during mask ventilation

Secondary Outcomes (20)

  • Correlation of difficult laryngoscopy with modified mallampati score

    Cormack Lehane score was assessed during laryngoscopy

  • Correlation of difficult mask ventilation with modified mallampati score

    Ventilation difficulty scale was assessed after during mask ventilation

  • Correlation of difficult laryngoscopy with neck movement

    Cormack Lehane score was assessed during laryngoscopy

  • with neck movement

    Ventilation difficulty scale was assessed during mask ventilation

  • Correlation of difficult laryngoscopy with dentition

    Cormack Lehane score was assessed during laryngoscopy

  • +15 more secondary outcomes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with body mass index (BMI) \> = 40, applied for elective surgery.

You may qualify if:

  • BMI \>= 40
  • American Society of Anesthesiologists (ASA) Physical Status I-III
  • Patients applied for elective surgery

You may not qualify if:

  • BMI \< 40
  • maxillofacial tumor or fracture
  • mass at the neck
  • mass in the thorax or mediastina
  • scar at the neck area
  • previous radiotherapy history to neck area
  • history of cervical vertebra operations
  • cervical vertebra structure abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (1)

  • Ozdilek A, Beyoglu CA, Erbabacan SE, Ekici B, Altindas F, Vehid S, Koksal GM. Correlation of Neck Circumference with Difficult Mask Ventilation and Difficult Laryngoscopy in Morbidly Obese Patients: an Observational Study. Obes Surg. 2018 Sep;28(9):2860-2867. doi: 10.1007/s11695-018-3263-3.

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Güniz Köksal, Professor

    Istanbul University Cerrahpasa Medical Faculty

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 20, 2015

First Posted

October 28, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 11, 2016

Record last verified: 2016-02

Locations