Other Conditions That May Be A Focus of Clinical AttentionNCT01888679
Influence of Head Positioning on the Movement of the Endotracheal Tube
A study testing Head movement in people with Other Conditions That May Be A Focus of Clinical Attention, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Other Conditions That May Be A Focus of Clinical Attention
- What is being tested?
- Head movement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2012to Mar 2013
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients older than 16 years
- ASA 1-2
- Elective surgery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Lausanne Hospitals
Lausanne, Canton of Vaud, 1011
About this study
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.
Read the 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.
- Being tested
- Head movement
- Keywords
- Airway, Endotracheal intubation, selective intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head movementProcedure or surgery
Head movement in extension, flexion, right and left rotation
| Study group | Role | What they receive |
|---|---|---|
| head movement | Experimental | head movement in extension, flexion, right and left rotation Receives: Procedure: Head movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Displacement of the endotracheal tube.
Tube movement related to movement of the head
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startAug 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other Conditions That May Be A Focus of Clinical AttentionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Schoettker,MD PD, University of Lausanne Hospitals
- Investigators
- Patrick Schoettker, MD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888679
- Sponsor's protocol ID
- 229/12
- Status last verified
- Feb 2020
- First submitted
- 21 Jun 2013
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 27290945
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Head Positioning on the Movement of the Endotracheal Tube
- ClinicalTrials.gov ID
- NCT01888679
- Acronym / sponsor ID
- 229/12
- Keywords
- Airway, Endotracheal intubation, selective intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 28 Jun 2013 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| head movement | Experimental | Procedure: Head movementhead movement in extension, flexion, right and left rotation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 16 years
- ASA 1-2
- Elective surgery
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head movementHead movement in extension, flexion, right and left rotation | Procedure or surgery | head movement |
Primary outcome
Displacement of the endotracheal tube.
Time frame: 24 hours
Tube movement related to movement of the head
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Results publication: PubMed 27290945Tailleur 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.
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.
Patrick Schoettker, MD principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head movement in people with Other Conditions That May Be A Focus of Clinical Attention, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 2 Mar 2020. 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 Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Displacement of the endotracheal tube. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01888679, which also lists 1 linked publication.
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 2 Mar 2020.