NCT02944305

Brief Summary

Failure in airway management is one of the most common anesthesia-related morbidity and mortality. Each individual airway assessment has limitation to predict difficult intubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

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

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

October 24, 2016

Last Update Submit

February 28, 2017

Conditions

Difficult Intubation

Outcome Measures

Primary Outcomes (1)

  • Difficult intubation

    Laryngoscopic view: grade 1-2 = no difficult intubation; grade 3-4 = difficult intubation

    5 minutes

Study Arms (1)

Patient with difficult intubation

Group 1: Patient undergoing endotracheal intubation with difficult intubation Group 2: Patient undergoing endotracheal intubation without difficult intubation

Procedure: Endotracheal intubation

Interventions

Endotracheal intubationPROCEDURE

Endotracheal intubation under direct laryngoscopy using McIntosh blade

Patient with difficult intubation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing general anesthesia with endotracheal intubation

You may qualify if:

  • Adult patients undergoing general anesthesia with endotracheal intubation

You may not qualify if:

  • Incomplete airway assessment in medical record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Srinagarind Hospital, Faculty of Medicine, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Related Publications (5)

  • 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: 9416711RESULT

  • Adnet F, Racine SX, Borron SW, Clemessy JL, Fournier JL, Lapostolle F, Cupa M. A survey of tracheal intubation difficulty in the operating room: a prospective observational study. Acta Anaesthesiol Scand. 2001 Mar;45(3):327-32. doi: 10.1034/j.1399-6576.2001.045003327.x.

    PMID: 11207469RESULT

  • Aktas S, Atalay YO, Tugrul M. Predictive value of bedside tests for difficult intubations. Eur Rev Med Pharmacol Sci. 2015;19(9):1595-9.

    PMID: 26004598RESULT

  • Iohom G, Ronayne M, Cunningham AJ. Prediction of difficult tracheal intubation. Eur J Anaesthesiol. 2003 Jan;20(1):31-6. doi: 10.1017/s0265021503000061.

    PMID: 12553386RESULT

  • Merah NA, Foulkes-Crabbe DJ, Kushimo OT, Ajayi PA. Prediction of difficult laryngoscopy in a population of Nigerian obstetric patients. West Afr J Med. 2004 Jan-Mar;23(1):38-41. doi: 10.4314/wajm.v23i1.28079.

    PMID: 15171524RESULT

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Sirirat Tribuddharat, MD

    Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 25, 2016

Study Start

September 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)