Head Movement Effect on Different Tracheal Tubes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by The Hospital for Sick Children.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00687583
First received: May 28, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  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 The Hospital for Sick Children:

Estimated Enrollment: 50
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

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687583

Contacts
Contact: Cengiz Karsli, MD 416-813-1500 ext 7341 cengiz.karsli@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Cengiz Karsli, MD    416 813-1500 ext 7341    cengiz.karsli@sickkids.ca   
Principal Investigator: Cenzig Karsli, MD         
Sub-Investigator: Gail Wong, MD         
Sub-Investigator: Justin John, MD         
Sub-Investigator: Bairbre Connolly, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Cengiz Karsli, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided

Responsible Party: Cengiz Karsli/Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00687583     History of Changes
Other Study ID Numbers: 1000010579
Study First Received: May 28, 2008
Last Updated: May 28, 2008
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on September 30, 2014