Hypercapnic Respiratory FailureNCT01489150
Use of EtCO2 as a PaCO2 Predictor Under Non Invasive Ventilation (NIV) in Cases 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 treated by Non invasive ventilation (NIV) due to acute hypercapnic respiratory failure, the interest of using the End-tidal Co2 measurement device "Capnostream" to evaluate PaCo2 and PaCo2 variations over time will be evaluated. 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
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2011to Dec 2012
- 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 arterial line requiring non invasive ventilation because of acute hypercapnic respiratory failure
Who may be able to join
- ICU patient equipped with arterial line
- NIV requirement
- Hypercapnia: PaCO2 > 45mmhg
Who cannot join
- Severe hemodynamic instability
- Severe psychiatric disorders
- nasal lesions
- denied consent
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 EtCO2 and Prolonged Expiratory Maneuvers as a PaCO2 Predictor in Cases of Acute Hypercapnic Respiratory Failure
In patients treated by Non invasive ventilation (NIV) due to acute hypercapnic respiratory failure, the interest of using the End-tidal Co2 measurement device "Capnostream" to evaluate PaCo2 and PaCo2 variations over time will be evaluated. Measurements will be done under normal expiration and under prolonged active and passive expiration maneuvers.
- Conditions
- Hypercapnic Respiratory Failure
- Keywords
- Acute respiratory failure, Hypercapnia, Non invasive ventilation, End-tidal CO2
- 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 EtCO2,PaCO2 and PaCO2 variation under NIV during both spontaneous expiration and prolonged expiration
Comparison between EtCO2,PaCO2 and PaCO2 variation under NIV during both spontaneous expiration and prolonged expiration
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 posted9 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2012
- Study completionDec 2012
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 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
- 11 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, Professor, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489150
- Sponsor's protocol ID
- EtCO2-NIV
- Status last verified
- May 2013
- First submitted
- 2 Dec 2011
- Last updated
- 16 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Piquilloud L, Thevoz D, Jolliet P, Revelly JP. End-tidal carbon dioxide monitoring using a naso-buccal sensor is not appropriate to monitor capnia during non-invasive ventilation. Ann Intensive Care. 2015 Feb 12;5:2. doi: 10.1186/s13613-014-0042-8. eCollection 2015.
PubMed 25852962
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of EtCO2 and Prolonged Expiratory Maneuvers as a PaCO2 Predictor in Cases of Acute Hypercapnic Respiratory Failure
- ClinicalTrials.gov ID
- NCT01489150
- Acronym / sponsor ID
- EtCO2-NIV
- Conditions
- Hypercapnic Respiratory Failure
- Keywords
- Acute respiratory failure, Hypercapnia, Non invasive ventilation, End-tidal CO2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Dec 2011 (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 treated by Non invasive ventilation (NIV) due to acute hypercapnic respiratory failure, the interest of using the End-tidal Co2 measurement device "Capnostream" to evaluate PaCo2 and PaCo2 variations over time will be evaluated. Measurements will be done under normal expiration and under prolonged active and passive expiration maneuvers.
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 arterial line requiring non invasive ventilation because of acute hypercapnic respiratory failure
Key inclusion criteria (3 listed)
- ICU patient equipped with arterial line
- NIV requirement
- Hypercapnia: PaCO2 > 45mmhg
Key exclusion criteria (4 listed)
- Severe hemodynamic instability
- Severe psychiatric disorders
- nasal lesions
- denied consent
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 EtCO2,PaCO2 and PaCO2 variation under NIV during both spontaneous expiration and prolonged expiration
Time frame: Sixty minutes
Comparison between EtCO2,PaCO2 and PaCO2 variation under NIV during both spontaneous expiration and prolonged expiration
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 16 May 2013.
- Derived from this study: PubMed 25852962Piquilloud L, Thevoz D, Jolliet P, Revelly JP. End-tidal carbon dioxide monitoring using a naso-buccal sensor is not appropriate to monitor capnia during non-invasive ventilation. Ann Intensive Care. 2015 Feb 12;5:2. doi: 10.1186/s13613-014-0042-8. eCollection 2015.
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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, Professor 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 16 May 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?
Comparison between EtCO2,PaCO2 and PaCO2 variation under NIV during both spontaneous expiration and prolonged expiration (time frame: Sixty minutes). 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 NCT01489150, 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 16 May 2013.