Sleep Apnea, ObstructiveNCT02290236
Monitored Saturation Post-ICU
An observational study of Sleep Apnea, Obstructive and Respiratory Insufficiency, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The overall aim with this project is to describe the correlation between measured and charted saturation after intensive care and also describe the saturation-pattern in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Respiratory Insufficiency
- What is being tested?
- Pulseoximetry
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2014to Jun 2017
- 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 that are discharged from the intensive care unit
Who may be able to join
- >18 years of age.
- Admitted to the Central Intensive Care Unit (CIVA)
- Signed informed conscent by the patient or a relative
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital, Solna
Stockholm, SE-17176
About this study
Official title: Monitored Saturation Post-ICU; Correlation to Charted Saturation, Pre-intensive Care Unit Obstructive Sleep Apnea and Outcome
The overall aim with this project is to describe the correlation between measured and charted saturation after intensive care and also describe the saturation-pattern in these patients. The investigators will also correlate post-ICU desaturations measured as oxygen denaturation index and complications to pre-ICU obstructive sleep apnea and the STOP BANG screening questionnaire.
- Being tested
- Pulseoximetry
- Medical subject headings
- Sleep Apnea, Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulseoximetryDevice
Also called Saturation
Peripheral saturation will be recorded continuously
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen desaturation index (ODI)
Measured by continuous pulseoximetry
Measured: Days
Secondary outcomes (1)
STOP Bang screening questionnaire
At inclusion the STOP BANG screening questionnaire will be completed
Measured: Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malin Jonsson Fagerlund, Karolinska University Hospital
- Investigators
- Malin Jonsson Fagerlund, MD, PhD, Principal investigator, Karolinska University Hospital and Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290236
- Sponsor's protocol ID
- Post ICU Sat
- Status last verified
- Oct 2016
- First submitted
- 6 Oct 2014
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitored Saturation Post-ICU; Correlation to Charted Saturation, Pre-intensive Care Unit Obstructive Sleep Apnea and Outcome
- ClinicalTrials.gov ID
- NCT02290236
- Acronym / sponsor ID
- Post ICU Sat
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 14 Nov 2014 (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 overall aim with this project is to describe the correlation between measured and charted saturation after intensive care and also describe the saturation-pattern in these patients. The investigators will also correlate post-ICU desaturations measured as oxygen denaturation index and complications to pre-ICU obstructive sleep apnea and the STOP BANG screening questionnaire.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that are discharged from the intensive care unit
Key inclusion criteria (3 listed)
- >18 years of age.
- Admitted to the Central Intensive Care Unit (CIVA)
- Signed informed conscent by the patient or a relative
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| PulseoximetryAlso: SaturationPeripheral saturation will be recorded continuously | Device | – |
Primary outcome
Oxygen desaturation index (ODI)
Time frame: Days
Measured by continuous pulseoximetry
1 secondary outcome
STOP Bang screening questionnaire
Time frame: Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
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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.
Malin Jonsson Fagerlund, MD, PhD principal investigator
Karolinska University Hospital and Karolinska Institutet
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 Sleep Apnea, Obstructive and Respiratory Insufficiency, run by Karolinska University Hospital at 1 site in Sweden.
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 1 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: status not confirmed, as of the sponsor's last update on 12 Oct 2016. 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 Sweden. 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?
Results are not available in the source record.
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?
Oxygen desaturation index (ODI) (time frame: Days). 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 12 Oct 2016; AzTrials last refreshed its copy on 27 Oct 2026.