Intubation, EndotrachealNCT01156233
Tube Tip Position in Orally Intubated 0-4year Old Children: Assessment of the Precision of Two Clinical Techniques
A study testing Anesthesia induction in people with Intubation, Endotracheal, run by Franz Frei at 1 site in Switzerland.
Trial summary
In pediatric anesthesia it is very important to place the endotracheal tube into the right position. This study compares two clinical location methods. The hypothesis means that the two techniques have the same precision of the location of the tip position of a cuffed MICROCUFF (Kimberly-Clark)endotracheal tube. Read more about this study
- Who is it for?
- Ages 1 day to 4 years
- Conditions the study is for
- Intubation, Endotracheal
- What is being tested?
- Anesthesia induction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2010to Dec 2011
- 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 1 day to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 0-4 years
- ASA I-II
- requiring endotracheal tube for surgical/diagnostic procedures
Who cannot join
- patients with abnormal airway anatomy
- kyphoscoliosis
- syndromes known to affect airway anatomy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitätskinderspital beider Basel
Basel, Basel, 4005
About this study
Official title: Endotracheal Tube Tip Position in Orally Intubated 0-4 Year Old Children: Comparative Assessment of the Precision of Two Clinical Techniques
In pediatric anesthesia it is very important to place the endotracheal tube into the right position. This study compares two clinical location methods. The hypothesis means that the two techniques have the same precision of the location of the tip position of a cuffed MICROCUFF (Kimberly-Clark)endotracheal tube.
Read the detailed description
Appropriate location of the tip of an endotracheal tube (TET), in relation to the carina and vocal cords, is of great importance in pediatric anesthesia. A not optimal laying tube causes life threatening consequences. Therefore, it is very essential to have reliable methods how to place the tube tip in regard of the precision of the localisation. There are no standardized methods how to accomplish a precise position. The study compares two most applied techniques. The first one is the cuff palpation technique (CPT), the second one the deliberate right mainstem intubation technique (RMT).
- Conditions
- Intubation, Endotracheal
- Being tested
- Anesthesia induction
- Keywords
- evaluating precision of tube tip position with two methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia inductionProcedure or surgery
Also called Pediatric endotracheal tube. Microcuff, Kimberly-Clark.
Cuff palpation technique: identification of the cuff position in the trachea by palpation.
Anesthesia inductionProcedure or surgery
Also called Pediatric endotracheal tube, Microcuff, Kimberly-Clark
Right mainstem intubation, identification of the tube tip position in the trachea by withdrawing the tube from the right mainstem until good quality breath sound in the left axilla are available.
| Study group | Role | What they receive |
|---|---|---|
| Cuff palpation technique | Experimental | Cuff palpation by the investigator's finger. Receives: Procedure: Anesthesia induction |
| Withdrawing tube technique | Experimental | Identification of the tube by withdrawing until good quality breath sounds Receives: Procedure: Anesthesia induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Localisation and precision of the tip of the endotracheal tube (TET) in the trachea
The study intends to determine the location and precision of the TET within the trachea that results from the use of two techniques. The measurements take place after the induction of the anesthesia and before surgery.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, EndotrachealStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Franz Frei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Franz Frei, University Hospital, Basel, Switzerland
- Investigators
- Franz Frei, Professor, Principal investigator, University Childrens Hospital beider Basel Postfach CH 4005 Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156233
- Sponsor's protocol ID
- UKBB_ANA_ TET
- Status last verified
- Feb 2013
- First submitted
- 30 Jun 2010
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endotracheal Tube Tip Position in Orally Intubated 0-4 Year Old Children: Comparative Assessment of the Precision of Two Clinical Techniques
- ClinicalTrials.gov ID
- NCT01156233
- Acronym / sponsor ID
- UKBB_ANA_ TET
- Conditions
- Intubation, Endotracheal
- Keywords
- evaluating precision of tube tip position with two methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Franz FreiUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Jul 2010 (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.
In pediatric anesthesia it is very important to place the endotracheal tube into the right position. This study compares two clinical location methods. The hypothesis means that the two techniques have the same precision of the location of the tip position of a cuffed MICROCUFF (Kimberly-Clark)endotracheal tube.
Detailed description
Appropriate location of the tip of an endotracheal tube (TET), in relation to the carina and vocal cords, is of great importance in pediatric anesthesia. A not optimal laying tube causes life threatening consequences. Therefore, it is very essential to have reliable methods how to place the tube tip in regard of the precision of the localisation. There are no standardized methods how to accomplish a precise position. The study compares two most applied techniques. The first one is the cuff palpation technique (CPT), the second one the deliberate right mainstem intubation technique (RMT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cuff palpation technique | Experimental | Procedure: Anesthesia inductionCuff palpation by the investigator's finger. |
| Withdrawing tube technique | Experimental | Procedure: Anesthesia inductionIdentification of the tube by withdrawing until good quality breath sounds |
Who may qualify
- Ages
- 1 day to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 0-4 years
- ASA I-II
- requiring endotracheal tube for surgical/diagnostic procedures
Key exclusion criteria (3 listed)
- patients with abnormal airway anatomy
- kyphoscoliosis
- syndromes known to affect airway anatomy
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 |
|---|---|---|
| Anesthesia inductionAlso: Pediatric endotracheal tube. Microcuff, Kimberly-Clark.Cuff palpation technique: identification of the cuff position in the trachea by palpation. | Procedure or surgery | Cuff palpation technique |
| Anesthesia inductionAlso: Pediatric endotracheal tube, Microcuff, Kimberly-ClarkRight mainstem intubation, identification of the tube tip position in the trachea by withdrawing the tube from the right mainstem until good quality breath sound in the left axilla are available. | Procedure or surgery | Withdrawing tube technique |
Primary outcome
Localisation and precision of the tip of the endotracheal tube (TET) in the trachea
Time frame: 10 minutes
The study intends to determine the location and precision of the TET within the trachea that results from the use of two techniques. The measurements take place after the induction of the anesthesia and before surgery.
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 12 Feb 2013.
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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.
Franz Frei, Professor principal investigator
University Childrens Hospital beider Basel Postfach CH 4005 Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anesthesia induction in people with Intubation, Endotracheal, run by Franz Frei 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 3 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 12 Feb 2013. 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?
Localisation and precision of the tip of the endotracheal tube (TET) in the trachea (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
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 12 Feb 2013.