Head MovementsNCT00687583
Head Movement Effect on Different Tracheal Tubes
An observational study of Head Movements and Intubation, Intratracheal, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 day to 6 years
- Conditions the study is for
- Head Movements, Intubation, Intratracheal
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2007to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 6 years
- All sexes
- No healthy volunteers
- Child
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).
Who may be able to join
- Children undergoing any procedure in the Image Guided Therapy (IGT) department requiring tracheal intubation and chest x-ray
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Head Movement on the Position of Different Tracheal Tubes Determined Radiologically
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.
Read the 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.
- Conditions
- Head Movements, Intubation, Intratracheal
- Keywords
- pediatrics, anesthesia, head movements, endotracheal tube
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startApr 2007
- Primary completionDec 2008 (estimated)
- Study completionJan 2009 (estimated)
Why it stopped: Research question deemed not of enough clinical importance to proceed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head MovementsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cengiz Karsli, The Hospital for Sick Children
- Investigators
- Cengiz Karsli, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687583
- Sponsor's protocol ID
- 1000010579
- Status last verified
- May 2016
- First submitted
- 28 May 2008
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Head Movement on the Position of Different Tracheal Tubes Determined Radiologically
- ClinicalTrials.gov ID
- NCT00687583
- Acronym / sponsor ID
- 1000010579
- Conditions
- Head Movements, Intubation, Intratracheal
- Keywords
- pediatrics, anesthesia, head movements, endotracheal tube
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Research question deemed not of enough clinical importance to proceed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 2 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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).
Key inclusion criteria (1 listed)
- Children undergoing any procedure in the Image Guided Therapy (IGT) department requiring tracheal intubation and chest x-ray
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cengiz Karsli, MD principal investigator
The Hospital for Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Movements and Intubation, Intratracheal, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016.