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Influence of Head Positioning on the Movement of the Endotracheal Tube

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ClinicalTrials.gov Identifier: NCT01888679
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Patrick Schoettker,MD PD, University of Lausanne Hospitals

Tracking Information
First Submitted Date  ICMJE June 21, 2013
First Posted Date  ICMJE June 28, 2013
Last Update Posted Date March 2, 2020
Study Start Date  ICMJE August 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2020)
Displacement of the endotracheal tube. [ Time Frame: 24 hours ]
Tube movement related to movement of the head
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
Displacement of the endotracheal tube. [ Time Frame: 24 hours ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Head Positioning on the Movement of the Endotracheal Tube
Official Title  ICMJE Influence of Head Positioning on the Movement of the Endotracheal Tube
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Other Conditions That May Be A Focus of Clinical Attention
Intervention  ICMJE Procedure: Head movement
Head movement in extension, flexion, right and left rotation
Study Arms  ICMJE Experimental: head movement
head movement in extension, flexion, right and left rotation
Intervention: Procedure: Head movement
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2013)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888679
Other Study ID Numbers  ICMJE 229/12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Patrick Schoettker,MD PD, University of Lausanne Hospitals
Study Sponsor  ICMJE University of Lausanne Hospitals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patrick Schoettker, MD University of Lausanne Hospitals
PRS Account University of Lausanne Hospitals
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP