Influence of Head Positioning on the Movement of the Endo... | NCT01888679

Studies
Influence of Head Positioning on the Movement of the Endotracheal Tube

NCT01888679

Sponsor

University of Lausanne Hospitals

Status

Completed

Last Update Posted

Mar 2, 2020Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Other Conditions That May Be A Focus of Clinical Attention

Interventions

Head movement

Countries

Switzerland

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

Feb 2020

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

Aug 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Jun 21, 2013

First Submission Date that Met QC Criteria

Jun 27, 2013

First Posted Date

Jun 28, 2013Estimated

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

Feb 27, 2020

Last Update Posted Date

Mar 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 purpose of this study is to evaluate and measure the movement of the endotracheal tube depending on the type and the amount of movement of the head of the patient intubated using a flexible fiberoptic.

Detailed Description

We performed a maximal head-neck movement trial on 50 adult patients, American Society of Anaesthesiologists 1 or 2. Patients with body mass index N35 kg · m-2, height b150 cm, airway malformations, pulmonary diseases, difficulties in neck flexion or extension, previous ENT surgery or radiotherapy, gastroesophageal reflux, or dental instability were excluded from the study.

We measured the change in distance between the ETT tip and the carina, using a fiberscope through the ETT.

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
head movement	Experimental	head movement in extension, flexion, right and left rotation	Procedure: Head movement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Head movement	Procedure	Head movement in extension, flexion, right and left rotation	head movement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Displacement of the endotracheal tube.	Tube movement related to movement of the head	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients older than 16 years
ASA 1-2
Elective surgery

Exclusion Criteria:

Pathological changes of the trachea.
Less than BMI 35 kg/m2.
Patients with rheumatoid arthritis or other limitation to cervical mobility.
Emergency surgery.
Individuals measuring less than 150 cm.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick Schoettker, MD	University of Lausanne Hospitals	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Lausanne Hospitals		Lausanne	Canton of Vaud	1011	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27290945	Result	Tailleur R, Bathory I, Dolci M, Frascarolo P, Kern C, Schoettker P. Endotracheal tube displacement during head and neck movements. Observational clinical trial. J Clin Anesth. 2016 Aug;32:54-8. doi: 10.1016/j.jclinane.2015.12.043. Epub 2016 Mar 22.

ID	Term
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena