NCT01888679

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

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

Study Start

First participant enrolled

August 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2013

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

June 21, 2013

Last Update Submit

February 27, 2020

Conditions

Other Conditions That May Be A Focus of Clinical Attention

Keywords

AirwayEndotracheal intubationselective intubation

Outcome Measures

Primary Outcomes (1)

  • Displacement of the endotracheal tube.

    Tube movement related to movement of the head

    24 hours

Study Arms (1)

head movement

EXPERIMENTAL

head movement in extension, flexion, right and left rotation

Procedure: Head movement

Interventions

Head movementPROCEDURE

Head movement in extension, flexion, right and left rotation

head movement

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 16 years
  • ASA 1-2
  • Elective surgery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lausanne Hospitals

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 27290945RESULT

MeSH Terms

Interventions

Head Movements

Intervention Hierarchy (Ancestors)

MovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Patrick Schoettker, MD

    University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 21, 2013

First Posted

June 28, 2013

Study Start

August 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 2, 2020

Record last verified: 2020-02

Locations

CH(1)