The Depth of Endotracheal Tube Insertion | NCT03184246

Studies
The Depth of Endotracheal Tube Insertion

NCT03184246

Sponsor

University Hospital Hradec Kralove

Status

Completed

Last Update Posted

Dec 6, 2018Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Intubation Complication

Interventions

GlideScope
Direct laryngoscopy

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2017Actual

Primary Completion Date

Dec 1, 2018Actual

Completion Date

Dec 4, 2018Actual

First Submitted Date

Jun 8, 2017

First Submission Date that Met QC Criteria

Jun 9, 2017

First Posted Date

Jun 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2018

Last Update Posted Date

Dec 6, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dostalova Vlasta, MD, PhD, MD, Ph.D., University Hospital Hradec KralovePrincipal Investigator

Lead Sponsor

University Hospital Hradec KraloveOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

100 patients scheduled for elective neurosurgical procedures will be randomized into two groups. Patients in group A will be intubated by videolaryngoscopy (GlideScope), patients in group B by direct laryngoscopy, in both groups will be rigid stylet used. Intubation will be done under propofol anesthesia, targeted entropy 40 to 50, and deep relaxation (neuromuscular transmission target level 0). Sufentanil will be used to block tracheal reflexes. In both groups the depth of insertion of tracheal tube will be measured in the mouth corner immediately after intubation. Next day, the unpleasant sensations and complications will be recorded (sore throat, stridor, hoarseness, cough and nausea and vomiting) during control visit of patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GlideScope	Experimental	intubation with GlideScope	Device: GlideScope
Direct laryngoscopy	Active Comparator	intubation with laryngoscope	Device: Direct laryngoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GlideScope	Device	videolaryngoscopy (GlideScope) will be used for intubation	GlideScope

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the depth of primary insertion of tracheal tube	cm	in a minute after intubation

Secondary Outcomes

Measure	Description	Time Frame
sums of manipulation with tracheal tube	number	2 minutes after intubation
complications after intubation	number	24 hours after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologists physical status I - III

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pavel Dostal, MD, Ph.D.	University Hospital Hradec Kralove	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Hradec Kralove		Hradec Králové		50005	Czechia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided