Sleep Disordered BreathingNCT01082575
Oxygen Monitoring of Patients After Surgery on the Hospital General Care Floor
An observational study of Sleep Disordered Breathing, run by Medtronic - MITG at 3 sites in United States.
Trial summary
The pain medication given after major surgery may cause some patients to stop breathing for periods of time especially at night time. An oxygen monitor may reflect this abnormal breathing pattern. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disordered Breathing
- What is being tested?
- Oxygen Monitoring
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2010to Aug 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Hospital Patients
Who may be able to join
- Age of 18 years or older
- Discharge from the post-anesthesia care unit (PACU) to the GCF after any of the following major surgeries: bariatric surgery, major orthopedic surgery (e.g., total hip replacement), major general surgery (e.g., bowel resections, open cholecystectomy), and major gynecological surgery (e.g., radical hysterectomy)
Who cannot join
- Pre-existing central neurological disease, including but not limited to recent traumatic brain injury, stroke, and neurodegenerative disease
- Ongoing use of mechanical ventilation or continuous positive airway pressure in the GCF
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Texas Health Research & Education Institute
Fort Worth, Texas, 76104
Tulane University
New Orleans, Louisiana, 70131
Santa Barbara Cottage Hospital
Santa Barbara, California, 93102
About this study
Official title: Oxygen Saturation Monitoring in the General Care Floor (GCF): An Observational Study of Repetitive Reductions in Airflow
The pain medication given after major surgery may cause some patients to stop breathing for periods of time especially at night time. An oxygen monitor may reflect this abnormal breathing pattern. This is an observational study of 100 post-operative patients who will be monitored with a pulse oximeter for a minimum of two nights and a maximum of five nights to determine the prevalence of this abnormal breathing pattern.
Read the detailed description
No further details necessary or available.
- Conditions
- Sleep Disordered Breathing
- Being tested
- Oxygen Monitoring
- Keywords
- Post Op Patients, Continuous Pulse Oximetry Monitoring, Major Surgery
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen MonitoringDevice
Also called Nellcor Pulse Oximeter, N600X
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Major Surgery | Oxygen Monitoring Receives: Device: Oxygen Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert.
Number of patients on the General care Floor in which a SPD (Saturation Pattern Detection) Alert occurs. Each patient wore a sensor on their finger continuously after surgery for up to 5 days. The sensor was attached to a Nellcor N600X oximeter which measures blood oxygen level. A SPD alert detects a patient's blood oxygen level that is increasing and decreasing in a pattern that is associated with periods of no breathing.
Measured: 5 days
Secondary outcomes (1)
Number of Participants With Adverse Events (AE) Caused by no Breathing
Number of participants with Airway Obstruction that caused the patient to stop breathing Number of participants with Cardiac arrest w/resuscitation caused by the patient not breathing
Measured: Five Nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep Disordered BreathingStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Mecca, MD, Study chair, Medtronic - MITG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082575
- Sponsor's protocol ID
- COV-MO-PO-A109
- Status last verified
- Aug 2014
- First submitted
- 5 Mar 2010
- Last updated
- 7 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Saturation Monitoring in the General Care Floor (GCF): An Observational Study of Repetitive Reductions in Airflow
- ClinicalTrials.gov ID
- NCT01082575
- Acronym / sponsor ID
- COV-MO-PO-A109
- Conditions
- Sleep Disordered Breathing
- Keywords
- Post Op Patients, Continuous Pulse Oximetry Monitoring, Major Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 8 Mar 2010 (estimated)
- Results
- Posted 4 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The pain medication given after major surgery may cause some patients to stop breathing for periods of time especially at night time. An oxygen monitor may reflect this abnormal breathing pattern. This is an observational study of 100 post-operative patients who will be monitored with a pulse oximeter for a minimum of two nights and a maximum of five nights to determine the prevalence of this abnormal breathing pattern.
Detailed description
No further details necessary or available.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Major Surgery | – | Device: Oxygen MonitoringOxygen Monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital Patients
Key inclusion criteria (2 listed)
- Age of 18 years or older
- Discharge from the post-anesthesia care unit (PACU) to the GCF after any of the following major surgeries: bariatric surgery, major orthopedic surgery (e.g., total hip replacement), major general surgery (e.g., bowel resections, open cholecystectomy), and major gynecological surgery (e.g., radical hysterectomy)
Key exclusion criteria (2 listed)
- Pre-existing central neurological disease, including but not limited to recent traumatic brain injury, stroke, and neurodegenerative disease
- Ongoing use of mechanical ventilation or continuous positive airway pressure in the GCF
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 |
|---|---|---|
| Oxygen MonitoringAlso: Nellcor Pulse Oximeter, N600XNo intervention | Device | Major Surgery |
Primary outcome
Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert.
Time frame: 5 days
Number of patients on the General care Floor in which a SPD (Saturation Pattern Detection) Alert occurs. Each patient wore a sensor on their finger continuously after surgery for up to 5 days. The sensor was attached to a Nellcor N600X oximeter which measures blood oxygen level. A SPD alert detects a patient's blood oxygen level that is increasing and decreasing in a pattern that is associated with periods of no breathing.
1 secondary outcome
Number of Participants With Adverse Events (AE) Caused by no Breathing
Time frame: Five Nights
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Roger Mecca, MD study chair
Medtronic - MITG
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disordered Breathing, run by Medtronic - MITG at 3 sites in United States.
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 7 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 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 4 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert. (time frame: 5 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 7 Aug 2014.