NCT03950934

Brief Summary

Primary aim of this study is to identify independent factors associated with difficult videolaryngoscopic intubation in patients undergoing oral and maxillofacial (OMF) or ear, nose and throat (ENT) surgery. Furthermore, this study intends to assess the diagnostic value of preoperative flexible nasal videoendoscopy to predict difficult videolaryngoscopic intubation in these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

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

April 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2020

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

May 13, 2019

Last Update Submit

May 28, 2020

Conditions

Keywords

AnesthesiaAirway ManagementIntubationBronchoscopesRisk AssessmentSurgery

Outcome Measures

Primary Outcomes (1)

  • Difficult videolaryngoscopic intubation

    Questionnaire

    30 minutes after endotracheal intubation

Secondary Outcomes (12)

  • Successful first intubation attempt

    30 minutes after endotracheal intubation

  • Overall success

    30 minutes after endotracheal intubation

  • Unsuccessful videolaryngoscopy

    30 minutes after endotracheal intubation

  • Severity of videolaryngoscopic intubation

    30 minutes after endotracheal intubation

  • Specific recommendations of the handling anesthetist

    30 minutes after endotracheal intubation

  • +7 more secondary outcomes

Interventions

Eligibility Criteria

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

ENT or OMF surgical patients presenting at the Anesthesiology Preassessment Clinic of the University Medical Center Hamburg-Eppendorf for preoperative risk assessment will be checked for eligibility. Repeated inclusions of participators are allowed.

You may qualify if:

  • Years and older
  • Patients scheduling for ENT or OMF surgery under general anesthesia with requirement of endotracheal Intubation
  • Risk of difficult airway management with confirmed indication for videolaryngoscopic intubation

You may not qualify if:

  • No consent given
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (2)

  • Peters T, Wunsch VA, Siebert H, Kohl V, Breitfeld P, Dankert A, Sasu PB, Dohrmann T, Krause L, Zollner C, Petzoldt M. What Is a Critical Mouth Opening for Macintosh Videolaryngoscopy? Results From a Prospective Observational Study. Anesth Analg. 2025 Oct 30. doi: 10.1213/ANE.0000000000007838. Online ahead of print.

  • Wunsch VA, Kohl V, Breitfeld P, Bauer M, Sasu PB, Siebert HK, Dankert A, Stark M, Zollner C, Petzoldt M. Hyperangulated blades or direct epiglottis lifting to optimize glottis visualization in difficult Macintosh videolaryngoscopy: a non-inferiority analysis of a prospective observational study. Front Med (Lausanne). 2023 Nov 30;10:1292056. doi: 10.3389/fmed.2023.1292056. eCollection 2023.

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Martin Petzoldt, PD Dr.

    Department of Anesthesiology, University Medical Center Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 15, 2019

Study Start

April 1, 2019

Primary Completion

April 5, 2020

Study Completion

May 1, 2020

Last Updated

May 29, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations