Oxygen Monitoring of Patients After Surgery on the Hospital General Care Floor
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ClinicalTrials.gov Identifier: NCT01082575 |
Recruitment Status :
Completed
First Posted : March 8, 2010
Results First Posted : October 4, 2012
Last Update Posted : August 7, 2014
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Sponsor:
Medtronic - MITG
Information provided by (Responsible Party):
Medtronic - MITG
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Tracking Information | ||||
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First Submitted Date | March 5, 2010 | |||
First Posted Date | March 8, 2010 | |||
Results First Submitted Date | February 8, 2012 | |||
Results First Posted Date | October 4, 2012 | |||
Last Update Posted Date | August 7, 2014 | |||
Study Start Date | February 2010 | |||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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.
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Original Primary Outcome Measures |
Prevalence of saturation patterns indicative of repetitive reductions in airflow [ Time Frame: Five Nights ] | |||
Change History | Complete list of historical versions of study NCT01082575 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
Number of Participants With Adverse Events (AE) Caused by no Breathing [ Time Frame: Five Nights ] 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
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Original Secondary Outcome Measures |
Determine whether the occurrence of saturation patterns indicative of repetitive reductions in airflow is associated with post-operative adverse events [ Time Frame: Five Nights ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Oxygen Monitoring of Patients After Surgery on the Hospital General Care Floor | |||
Official Title | Oxygen Saturation Monitoring in the General Care Floor (GCF): An Observational Study of Repetitive Reductions in Airflow | |||
Brief 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. 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 Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Hospital Patients | |||
Condition | Sleep Disordered Breathing | |||
Intervention | Device: Oxygen Monitoring
No intervention
Other Names:
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Study Groups/Cohorts | Major Surgery
Oxygen Monitoring
Intervention: Device: Oxygen Monitoring
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
100 | |||
Original Estimated Enrollment | Same as current | |||
Actual Study Completion Date | August 2010 | |||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01082575 | |||
Other Study ID Numbers | COV-MO-PO-A109 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Medtronic - MITG | |||
Study Sponsor | Medtronic - MITG | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Medtronic - MITG | |||
Verification Date | August 2014 |