Intubation, EndotrachealNCT00968058
Leak Pressure of Uncuffed Pediatric Endotracheal Tubes
An observational study of Intubation, Endotracheal and Leak Pressure, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Children and adults frequently need a 'breathing tube' when having anesthesia for surgery. The breathing tube is usually inserted after the anesthesia doctor puts a patient to sleep with medicine, so they do not feel the breathing tube. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Intubation, Endotracheal, Leak Pressure
- What is being tested?
- Leak Test Recording
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jul 2011
- 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 Up to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients undergoing surgical procedures at Oregon Health \& Science University
Who may be able to join
- Children aged 0-7 years of age
- Surgery with planned endotracheal intubation using an uncuffed ETT.
- ASA 1-3
- Supine position
Who cannot join
- Lack of parental consent
- Rapid sequence induction with cricoid pressure
- Use of neuromuscular blocking agent/s for intubation.
- Active gastroesophageal reflux disease
- Active upper respiratory tract infection
- Chronic active lung disease requiring frequent treatment such as asthma, or chronic lung disease of prematurity etc.
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- Surgery in the lateral or prone position
- Oropharyngeal, neck , laryngeal, or laparoscopic surgery
- Tracheostomy in-situ
- History of previous laryngeal or tracheal surgery
- History of tracheal or laryngeal abnormalities, or stridor of unknown origin.
- History of symptomatic neuromuscular disease or paralysis
- History or features suggestive of a difficult airway on pre-anesthetic evaluation and physical examination.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Temporal Variation of the Leak Pressure of Uncuffed Pediatric Endotracheal Tubes Following Intubation: A Prospective Observational Study
Children and adults frequently need a 'breathing tube' when having anesthesia for surgery. The breathing tube is usually inserted after the anesthesia doctor puts a patient to sleep with medicine, so they do not feel the breathing tube. In children, there is often a leak of air between the tube and the windpipe, as the tube is not an exact fit. Anesthesia doctors usually listen for this leak around the tube by listening to the chest with a stethoscope while gently filling the lungs with oxygen from the anesthesia machine. The leak tells them if the tube is the correct size, or too small, or too tight. If it is too small, or too tight, they usually change the tube for a better fit.
The purpose of this study is to see what happens to this leak in the 30 minutes after the tube is placed. No one really knows if the leak gets bigger, smaller, or stays the same. Knowing what happens to the leak will help anesthesia doctors to decide whether to change the breathing tube or not. This is important, as a tube that is too tight can lead to breathing difficulty after removing the tube at the end of surgery, and a tube that is too small may make it difficult for the breathing machine to work effectively for the patient as a result of a large leak of air or oxygen.
- Conditions
- Intubation, Endotracheal, Leak Pressure
- Being tested
- Leak Test Recording
- Keywords
- Leak Pressure, Intubation, Endotracheal, Pediatric, Temporal Variation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leak Test RecordingProcedure or surgery
Recording of the Leak Pressure by the Leak Test at 0, 5, 10, 15, 20, 30 min timepoints
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in leak pressure following endotracheal tube placement
Measured: Thirty minutes after tube placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2011
- Study completionJul 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.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirk Lalwani, Oregon Health and Science University
- Investigators
- Kirk Lalwani, MD, Principal investigator, Oregon Health and Science UniversityShreya J Patel, BS, Study director, University of Arizona College of MedicineJeffrey Koh, MD, Study director, Oregon Health and Science UniversityRochelle Fu, PhD, Study director, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968058
- Sponsor's protocol ID
- IRB00005347
- Status last verified
- May 2012
- First submitted
- 27 Aug 2009
- Last updated
- 4 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Variation of the Leak Pressure of Uncuffed Pediatric Endotracheal Tubes Following Intubation: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT00968058
- Acronym / sponsor ID
- IRB00005347
- Conditions
- Intubation, Endotracheal, Leak Pressure
- Keywords
- Leak Pressure, Intubation, Endotracheal, Pediatric, Temporal Variation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 28 Aug 2009 (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.
Children and adults frequently need a 'breathing tube' when having anesthesia for surgery. The breathing tube is usually inserted after the anesthesia doctor puts a patient to sleep with medicine, so they do not feel the breathing tube. In children, there is often a leak of air between the tube and the windpipe, as the tube is not an exact fit. Anesthesia doctors usually listen for this leak around the tube by listening to the chest with a stethoscope while gently filling the lungs with oxygen from the anesthesia machine. The leak tells them if the tube is the correct size, or too small, or too tight. If it is too small, or too tight, they usually change the tube for a better fit.
The purpose of this study is to see what happens to this leak in the 30 minutes after the tube is placed. No one really knows if the leak gets bigger, smaller, or stays the same. Knowing what happens to the leak will help anesthesia doctors to decide whether to change the breathing tube or not. This is important, as a tube that is too tight can lead to breathing difficulty after removing the tube at the end of surgery, and a tube that is too small may make it difficult for the breathing machine to work effectively for the patient as a result of a large leak of air or oxygen.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients undergoing surgical procedures at Oregon Health \& Science University
Key inclusion criteria (4 listed)
- Children aged 0-7 years of age
- Surgery with planned endotracheal intubation using an uncuffed ETT.
- ASA 1-3
- Supine position
Key exclusion criteria (13 listed)
- Lack of parental consent
- Rapid sequence induction with cricoid pressure
- Use of neuromuscular blocking agent/s for intubation.
- Active gastroesophageal reflux disease
- Active upper respiratory tract infection
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 |
|---|---|---|
| Leak Test RecordingRecording of the Leak Pressure by the Leak Test at 0, 5, 10, 15, 20, 30 min timepoints | Procedure or surgery | – |
Primary outcome
Changes in leak pressure following endotracheal tube placement
Time frame: Thirty minutes after tube placement
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 4 May 2012.
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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.
Kirk Lalwani, MD principal investigator
Oregon Health and Science University
Shreya J Patel, BS study director
University of Arizona College of Medicine
Jeffrey Koh, MD study director
Oregon Health and Science University
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 Intubation, Endotracheal and Leak Pressure, run by Oregon Health and Science University at 1 site in United States.
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 4 inclusion and 13 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 4 May 2012. 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 United States. 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?
Changes in leak pressure following endotracheal tube placement (time frame: Thirty minutes after tube placement). 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 4 May 2012.