Endotracheal PressureNCT00866255
Continuous Measurement of Intratracheal Pressure
A study testing endotracheal tube pressure measurement probe in people with Endotracheal Pressure, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
Continuous measurement of intratracheal pressure in mechanically ventilated infants using a fibreoptic pressure transducer in the endotracheal tube (ETT). Based on the findings, tracheal pressure can continuously be monitored in the presence of pediatric ETTs by combining ETT coefficients and the flow and airway… Read more about this study
- Who is it for?
- Ages 1 day to 10 years
- Conditions the study is for
- Endotracheal Pressure
- What is being tested?
- endotracheal tube pressure measurement probe
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to May 2009
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children < 10 Years
- volume-controlled ventilation
Who cannot join
- refusal of written informed consent
- severe pulmonary diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Measurement of Intratracheal Pressure in Mechanically Ventilated Infants
Continuous measurement of intratracheal pressure in mechanically ventilated infants using a fibreoptic pressure transducer in the endotracheal tube (ETT). Based on the findings, tracheal pressure can continuously be monitored in the presence of pediatric ETTs by combining ETT coefficients and the flow and airway pressure continuously measured at the proximal end of the ETT.
- Conditions
- Endotracheal Pressure
- Being tested
- endotracheal tube pressure measurement probe
- Keywords
- endotracheal tube, endotracheal pressure, airway pressure, pressure drop, calculation, continuous calculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endotracheal tube pressure measurement probeDevice
The endotracheal tube pressure measurement probe is inserted into the endotracheal tube prior to intubation for measurement of tracheal pressure at the tip of the endotracheal tube.
What is being measured
The primary outcome is the main question the study is designed to answer.
tracheal pressure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startJan 2008
- Primary completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endotracheal PressureStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866255
- Sponsor's protocol ID
- 237/06
- Status last verified
- Mar 2009
- First submitted
- 19 Mar 2009
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Guttmann J, Kessler V, Mols G, Hentschel R, Haberthur C, Geiger K. Continuous calculation of intratracheal pressure in the presence of pediatric endotracheal tubes. Crit Care Med. 2000 Apr;28(4):1018-26. doi: 10.1097/00003246-200004000-00018.
PubMed 10809276Guttmann J, Eberhard L, Fabry B, Bertschmann W, Wolff G. Continuous calculation of intratracheal pressure in tracheally intubated patients. Anesthesiology. 1993 Sep;79(3):503-13. doi: 10.1097/00000542-199309000-00014.
PubMed 8363076Spaeth J, Steinmann D, Kaltofen H, Guttmann J, Schumann S. The pressure drop across the endotracheal tube in mechanically ventilated pediatric patients. Paediatr Anaesth. 2015 Apr;25(4):413-20. doi: 10.1111/pan.12595. Epub 2014 Dec 10.
PubMed 25491944
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Measurement of Intratracheal Pressure in Mechanically Ventilated Infants
- ClinicalTrials.gov ID
- NCT00866255
- Acronym / sponsor ID
- 237/06
- Conditions
- Endotracheal Pressure
- Keywords
- endotracheal tube, endotracheal pressure, airway pressure, pressure drop, calculation, continuous calculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- May 2009 (actual)
- First posted
- 20 Mar 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.
Continuous measurement of intratracheal pressure in mechanically ventilated infants using a fibreoptic pressure transducer in the endotracheal tube (ETT). Based on the findings, tracheal pressure can continuously be monitored in the presence of pediatric ETTs by combining ETT coefficients and the flow and airway pressure continuously measured at the proximal end of the ETT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 day to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children < 10 Years
- volume-controlled ventilation
Key exclusion criteria (2 listed)
- refusal of written informed consent
- severe pulmonary diseases
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 |
|---|---|---|
| endotracheal tube pressure measurement probeThe endotracheal tube pressure measurement probe is inserted into the endotracheal tube prior to intubation for measurement of tracheal pressure at the tip of the endotracheal tube. | Device | – |
Primary outcome
tracheal pressure
Time frame: 2 years
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 Feb 2010.
- Background: PubMed 10809276Guttmann J, Kessler V, Mols G, Hentschel R, Haberthur C, Geiger K. Continuous calculation of intratracheal pressure in the presence of pediatric endotracheal tubes. Crit Care Med. 2000 Apr;28(4):1018-26. doi: 10.1097/00003246-200004000-00018.
- Background: PubMed 8363076Guttmann J, Eberhard L, Fabry B, Bertschmann W, Wolff G. Continuous calculation of intratracheal pressure in tracheally intubated patients. Anesthesiology. 1993 Sep;79(3):503-13. doi: 10.1097/00000542-199309000-00014.
- Derived from this study: PubMed 25491944Spaeth J, Steinmann D, Kaltofen H, Guttmann J, Schumann S. The pressure drop across the endotracheal tube in mechanically ventilated pediatric patients. Paediatr Anaesth. 2015 Apr;25(4):413-20. doi: 10.1111/pan.12595. Epub 2014 Dec 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endotracheal tube pressure measurement probe in people with Endotracheal Pressure, run by University Hospital Freiburg at 1 site in Germany.
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 2 inclusion and 2 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 Feb 2010. 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 Germany. 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?
tracheal pressure (time frame: 2 years). 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 NCT00866255, which also lists 3 linked publications.
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 Feb 2010.