NCT03184246

Brief Summary

The investigators suppose that direct laryngoscopy is connected with deeper insertion of endotracheal tube in comparison to videolaryngoscopy. Correction of this malposition can cause postoperative discomfort and further complications in some patients.Routine use of videolaryngoscopy could minimize these problems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

June 30, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2018

Completed
Last Updated

December 6, 2018

Status Verified

December 1, 2018

Enrollment Period

1.4 years

First QC Date

June 8, 2017

Last Update Submit

December 5, 2018

Conditions

Keywords

Videolaryngoscopy (GlideScope)Direct laryngoscopy

Outcome Measures

Primary Outcomes (1)

  • the depth of primary insertion of tracheal tube

    cm

    in a minute after intubation

Secondary Outcomes (2)

  • sums of manipulation with tracheal tube

    2 minutes after intubation

  • complications after intubation

    24 hours after surgery

Study Arms (2)

GlideScope

EXPERIMENTAL

intubation with GlideScope

Device: GlideScope

Direct laryngoscopy

ACTIVE COMPARATOR

intubation with laryngoscope

Device: Direct laryngoscopy

Interventions

videolaryngoscopy (GlideScope) will be used for intubation

GlideScope

direct laryngoscopy will be used for intubation

Direct laryngoscopy

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiologists physical status I - III

You may not qualify if:

  • postoperative ventilation, laryngeal tumors, conditions after tracheotomy or laryngeal operations, cervical spinal hernia extraction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location

Study Officials

  • Pavel Dostal, MD, Ph.D.

    University Hospital Hradec Kralove

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Interventional group will be intubated by videolaryngoscopy, control group by direct laryngoscopy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D.

Study Record Dates

First Submitted

June 8, 2017

First Posted

June 12, 2017

Study Start

June 30, 2017

Primary Completion

December 1, 2018

Study Completion

December 4, 2018

Last Updated

December 6, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations