NCT04724408

Brief Summary

Patients requiring endotracheal intubation for elective surgery without expected difficult airway are randomized to be intubated either by a) VieScope or b) conventional direct laryngoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

January 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 26, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

1 month

First QC Date

January 23, 2021

Last Update Submit

April 7, 2021

Conditions

Airway Management

Outcome Measures

Primary Outcomes (1)

  • First attempt success rate

    percentage of successful intubations with one attempt

    15 min

Secondary Outcomes (11)

  • intubating conditions

    15 min

  • overall success rate

    15 min

  • time to successful intubation

    15 min

  • time to successful intubation with one attempt

    15 min

  • intubation difficulty

    15 min

  • +6 more secondary outcomes

Study Arms (2)

VieScope

EXPERIMENTAL

intubation with the VieScope laryngoscope

Device: VieScope

Conventional

ACTIVE COMPARATOR

intubation with MacIntosh-type laryngoscope

Device: Conventional

Interventions

VieScopeDEVICE

see above

VieScope
ConventionalDEVICE

see above

Conventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients requiring general anesthesia with transoral tracheal intubation for elective surgery
  • Age ≥ 18
  • Preoperative airway assessment reveals an expected non-difficult airway (rated by the responsible anesthetist in the Pre-assessment Clinic based on the existing in-house algorithm)

You may not qualify if:

  • Pregnant or breastfeeding woman
  • Confirmed indications for awake fiberoptic intubation especially due to enoral, pharyngeal tumors, abscesses or other processes
  • Planned endotracheal intubation without deep anesthesia or neuromuscular blocking agents (e.g. awake videolaryngoscopy)
  • Required transnasal tracheal intubation (e.g. for surgical reasons)
  • Requirement of special endotracheal tubes such as laser or RAE tubes for surgical reasons
  • Patients at risk for pulmonary aspiration who qualify for rapid sequence induction
  • Loose teeth
  • Denial of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

Study Officials

  • Joern Grensemann, MD

    Universitätsklinikum Hamburg-Eppendorf

    STUDY CHAIR

  • Martin Petzoldt, MD

    Universitätsklinikum Hamburg-Eppendorf

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
device for intubation may not be blinded for provider or investigator
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized 1:1
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2021

First Posted

January 26, 2021

Study Start

January 26, 2021

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations

DE(1)