HypoventilationNCT01845233
Monitoring of Non-invasive Ventilation
An observational study of Hypoventilation, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to determine whether clinical examination, report from ventilator software, nocturnal Sp02 and daytime arterial blood gas are sufficient as screening tools to reveal clinical relevant problems with patients receiving long term treatment with non invasive ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoventilation
- How many people
- 67 participants
- Where
- 1 siteNorway
- Study dates
- May 2013to Jun 2014
- 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: Patients with chronic hypoventilation treated with long term mechanical ventilation
Who may be able to join
None listed.
Who cannot join
- Under 18 years old
- Lack of cooperation
- Pregnant
- Acute exacerbation last 3 month leading to hospital admission.
- Change of treatment last 3 month
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether clinical examination, report from ventilator software, nocturnal Sp02 and daytime arterial blood gas are sufficient as screening tools to reveal clinical relevant problems with patients receiving long term treatment with non invasive ventilation.
Read the detailed description
Patient with chronic hypoventilation with stable on long term treatment (LTMV) with non-invasive ventilation for at least 3 month taking part of our LTMV program will be included.
In addition to clinical examination,report from ventilator software, nocturnal Sp02 and daytime arterial blood gas all patients will be investigated with sleep polygraphy and transcutaneous Co2.
- Conditions
- Hypoventilation
- Medical subject headings
- Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non invasive ventilation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of transcutaneous co2 revealing sleep hypoventilation, when nocturnal pulseoximeter is normal
Measured: single night study
Secondary outcomes (1)
Frequency of patient-ventilator asynchrony during non invasive ventilation ?
Measured: Single night study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2014
- Study completionJun 2014
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 HypoventilationStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Cross-sectional
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, Trondheim University Hospital, University Hospital, Geneva
- Responsible party
- Sponsor
- Investigators
- Sigurd aarrestad, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845233
- Sponsor's protocol ID
- 2012/1142(REK)
- Status last verified
- Aug 2014
- First submitted
- 11 Mar 2013
- Last updated
- 25 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Aarrestad S, Qvarfort M, Kleiven AL, Tollefsen E, Skjonsberg OH, Janssens JP. Diagnostic accuracy of simple tools in monitoring patients with chronic hypoventilation treated with non-invasive ventilation; a prospective cross-sectional study. Respir Med. 2018 Nov;144:30-35. doi: 10.1016/j.rmed.2018.09.015. Epub 2018 Sep 26.
PubMed 30366581Aarrestad S, Qvarfort M, Kleiven AL, Tollefsen E, Skjonsberg OH, Janssens JP. Sleep related respiratory events during non-invasive ventilation of patients with chronic hypoventilation. Respir Med. 2017 Nov;132:210-216. doi: 10.1016/j.rmed.2017.10.025. Epub 2017 Nov 2.
PubMed 29229100Aarrestad S, Tollefsen E, Kleiven AL, Qvarfort M, Janssens JP, Skjonsberg OH. Validity of transcutaneous PCO2 in monitoring chronic hypoventilation treated with non-invasive ventilation. Respir Med. 2016 Mar;112:112-8. doi: 10.1016/j.rmed.2016.01.017. Epub 2016 Jan 27.
PubMed 26874895
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Non-invasive Ventilation
- ClinicalTrials.gov ID
- NCT01845233
- Acronym / sponsor ID
- 2012/1142(REK)
- Conditions
- Hypoventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, Trondheim University Hospital, University Hospital, Geneva
- Study start
- May 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 3 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.
The purpose of this study is to determine whether clinical examination, report from ventilator software, nocturnal Sp02 and daytime arterial blood gas are sufficient as screening tools to reveal clinical relevant problems with patients receiving long term treatment with non invasive ventilation.
Detailed description
Patient with chronic hypoventilation with stable on long term treatment (LTMV) with non-invasive ventilation for at least 3 month taking part of our LTMV program will be included.
In addition to clinical examination,report from ventilator software, nocturnal Sp02 and daytime arterial blood gas all patients will be investigated with sleep polygraphy and transcutaneous Co2.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non invasive ventilation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hypoventilation treated with long term mechanical ventilation
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Under 18 years old
- Lack of cooperation
- Pregnant
- Acute exacerbation last 3 month leading to hospital admission.
- Change of treatment last 3 month
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
Frequency of transcutaneous co2 revealing sleep hypoventilation, when nocturnal pulseoximeter is normal
Time frame: single night study
1 secondary outcome
Frequency of patient-ventilator asynchrony during non invasive ventilation ?
Time frame: Single night study
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 25 Aug 2014.
- Derived from this study: PubMed 30366581Aarrestad S, Qvarfort M, Kleiven AL, Tollefsen E, Skjonsberg OH, Janssens JP. Diagnostic accuracy of simple tools in monitoring patients with chronic hypoventilation treated with non-invasive ventilation; a prospective cross-sectional study. Respir Med. 2018 Nov;144:30-35. doi: 10.1016/j.rmed.2018.09.015. Epub 2018 Sep 26.
- Derived from this study: PubMed 29229100Aarrestad S, Qvarfort M, Kleiven AL, Tollefsen E, Skjonsberg OH, Janssens JP. Sleep related respiratory events during non-invasive ventilation of patients with chronic hypoventilation. Respir Med. 2017 Nov;132:210-216. doi: 10.1016/j.rmed.2017.10.025. Epub 2017 Nov 2.
- Derived from this study: PubMed 26874895Aarrestad S, Tollefsen E, Kleiven AL, Qvarfort M, Janssens JP, Skjonsberg OH. Validity of transcutaneous PCO2 in monitoring chronic hypoventilation treated with non-invasive ventilation. Respir Med. 2016 Mar;112:112-8. doi: 10.1016/j.rmed.2016.01.017. Epub 2016 Jan 27.
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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.
Sigurd aarrestad, MD principal investigator
Oslo University Hospital
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 Hypoventilation, run by Oslo University Hospital at 1 site in Norway.
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 0 inclusion and 5 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 25 Aug 2014. 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 Norway. 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?
Frequency of transcutaneous co2 revealing sleep hypoventilation, when nocturnal pulseoximeter is normal (time frame: single night study). 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 NCT01845233, 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 25 Aug 2014.