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Head Movement Effect on Different Tracheal Tubes

This study has been withdrawn prior to enrollment.
(Research question deemed not of enough clinical importance to proceed.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00687583
First Posted: June 2, 2008
Last Update Posted: May 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cengiz Karsli, The Hospital for Sick Children
  Purpose
A breathing tube, which is used to secure the airway and allow ventilation of the lungs during general anaesthesia, is inserted into the windpipe either through the nose or mouth. In children, different formulas exist to determine the appropriate size of the tube according to age, and how far it should be advanced into the airway. Head movement can alter the position of the breathing tube, making it go in or come out too far. Different types of breathing tubes may also differ in their change of position with head movement. The aim of this study is to assess the accuracy of the formulae commonly used in our institution for depth of breathing tube placement, and to measure the degree of tube displacement on head movement with different types of tubes.

Condition Phase
Head Movements Intubation, Intratracheal Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Head Movement on the Position of Different Tracheal Tubes Determined Radiologically

Further study details as provided by Cengiz Karsli, The Hospital for Sick Children:

Enrollment: 0
Study Start Date: April 2007
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

An endotracheal tube, which is used to secure the airway and allow ventilation of the lungs during general anesthesia, is inserted into the trachea either through the nose or mouth. In children, different formulae exist to determine the approximate size of the tube according to age, and how far it should be advanced into the airway. Once a tracheal tube is inserted, its position is routinely checked to make sure both lungs are ventilated. To prevent displacement, the tube is taped to the lip, chin or at the nose. However, head movement could cause alteration of the tube position, and risk selective endobronchial intubation or inadvertent extubation. Knowledge of how the different tracheal tubes move with head position can help determine the best tube selection to reduce the risk of accidental tube advancement or removal, in cases where certain head positions are required for surgical access.

The aim of this study is to assess the accuracy of the formulae commonly used in our institution for depth of breathing tube placement, and to measure the degree of tube displacement on head movement with different types of tube. Testing the formulae will enable us to be more aware of how frequently inaccurate tube placement may occur. Knowledge of how the different breathing tubes move with head position can help determine the best tube selection to reduce the risk of the tube going in too far or coming out accidentally, for cases were certain head positions are required for surgery.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Fifty children undergoing any procedure in the Image Guided Therapy (IGT) department requiring tracheal intubation and chest X-ray, will be recruited and will be evenly distributed in three different age groups (0 to 6 months, 6 to 24 months, 24 months to 6 years).
Criteria

Inclusion Criteria:

  • Children undergoing any procedure in the Image Guided Therapy (IGT) department requiring tracheal intubation and chest x-ray

Exclusion Criteria:

  • Premature neonates
  • Patients with cranio-facial anomalies
  • Cervical spine/upper thoracic anomalies
  • Laryngomalacia/tracheomalacia
  • Chronic hypoxemia (i.e. cardiac conditions with right to left shunts)
  • Patients requiring positions other than supine
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00687583


Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Cengiz Karsli, MD The Hospital for Sick Children, Toronto Canada
  More Information

Responsible Party: Cengiz Karsli, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00687583     History of Changes
Other Study ID Numbers: 1000010579
First Submitted: May 28, 2008
First Posted: June 2, 2008
Last Update Posted: May 4, 2016
Last Verified: May 2016

Keywords provided by Cengiz Karsli, The Hospital for Sick Children:
pediatrics
anesthesia
head movements
endotracheal tube