Hypercapnic Respiratory FailureTpCO2-NIVNCT01857635
Use of TpCO2 (Transcutaneous CO2 Measurement) as PaCO2 Predictor During NIV in Case of Acute Hypercapnic Respiratory Failure
An observational study of Hypercapnic Respiratory Failure, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
In patients suffering from hypercapnic respiratory failure and treated by non invasive ventilation (NIV), the interest of using transcutaneous CO2 measurement to evaluate PaCO2 and PaCO2 variation over time is unknown and will be evaluated in this study. Measurements will be done during one-hour NIV treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercapnic Respiratory Failure
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2013to Mar 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive care unit patients equipped with an arterial line and requiring non invasive ventilation because of acute hypercapnic respiratory failure
Who may be able to join
- ICU patient equipped with an arterial line
- NIV treatment prescribed by the clinician in charge
- Hypercapnia defined by PaCO2> 42mmHg
Who cannot join
- Severe hemodynamic instability
- Severe psychiatric disorders
- Denied consent
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Intensive care and burn unit, University hospital of Lausanne
Lausanne, 1011
About this study
Official title: Use of TpCO2 (Transcutaneous CO2 Measurement)as PaCO2 Predictor During Non Invasive Ventilation (NIV) in Case of Acute Hypercapnic Respiratory Failure
In patients suffering from hypercapnic respiratory failure and treated by non invasive ventilation (NIV), the interest of using transcutaneous CO2 measurement to evaluate PaCO2 and PaCO2 variation over time is unknown and will be evaluated in this study. Measurements will be done during one-hour NIV treatments.
- Conditions
- Hypercapnic Respiratory Failure
- Keywords
- Acute respiratory failure, Hypercapnia, Non invasive ventilation, Transcutaneous CO2 measurement
- Medical subject headings
- Respiratory Insufficiency, Hypercapnia
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between TpCO2 (transcutaneous non invasive CO2 partial pressure measurement) and PaCO2 (obtained by blood gas analysis) values during NIV treatment.
Measured: sixty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypercapnic Respiratory FailureStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Philippe Jolliet, University of Lausanne Hospitals
- Investigators
- Philippe Jolliet, Prof, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857635
- Sponsor's protocol ID
- TpCO2-NIV
- Acronym
- TpCO2-NIV
- Status last verified
- Jun 2015
- First submitted
- 15 May 2013
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of TpCO2 (Transcutaneous CO2 Measurement)as PaCO2 Predictor During Non Invasive Ventilation (NIV) in Case of Acute Hypercapnic Respiratory Failure
- ClinicalTrials.gov ID
- NCT01857635
- Acronym / sponsor ID
- TpCO2-NIV / TpCO2-NIV
- Conditions
- Hypercapnic Respiratory Failure
- Keywords
- Acute respiratory failure, Hypercapnia, Non invasive ventilation, Transcutaneous CO2 measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 May 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.
In patients suffering from hypercapnic respiratory failure and treated by non invasive ventilation (NIV), the interest of using transcutaneous CO2 measurement to evaluate PaCO2 and PaCO2 variation over time is unknown and will be evaluated in this study. Measurements will be done during one-hour NIV treatments.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care unit patients equipped with an arterial line and requiring non invasive ventilation because of acute hypercapnic respiratory failure
Key inclusion criteria (3 listed)
- ICU patient equipped with an arterial line
- NIV treatment prescribed by the clinician in charge
- Hypercapnia defined by PaCO2> 42mmHg
Key exclusion criteria (4 listed)
- Severe hemodynamic instability
- Severe psychiatric disorders
- Denied consent
- Age < 18 years
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
Comparison between TpCO2 (transcutaneous non invasive CO2 partial pressure measurement) and PaCO2 (obtained by blood gas analysis) values during NIV treatment.
Time frame: sixty minutes
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 9 Jun 2015.
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RESET-COPD Cohort: Real-Time Monitoring and Early Warning in COPD Patients Receiving Home NPPV
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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.
Philippe Jolliet, Prof 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?
An observational study of Hypercapnic Respiratory Failure, 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 4 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 9 Jun 2015. 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?
Comparison between TpCO2 (transcutaneous non invasive CO2 partial pressure measurement) and PaCO2 (obtained by blood gas analysis) values during NIV treatment. (time frame: sixty 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 9 Jun 2015.