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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
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Tracking Information
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
 (submitted: September 4, 2012)
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.
Original Primary Outcome Measures
 (submitted: March 5, 2010)
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
 (submitted: September 4, 2012)
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
Original Secondary Outcome Measures
 (submitted: March 5, 2010)
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
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:
  • Nellcor Pulse Oximeter
  • N600X
Study Groups/Cohorts Major Surgery
Oxygen Monitoring
Intervention: Device: Oxygen Monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 5, 2010)
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:

  • 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)

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
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
Study Chair: Roger Mecca, MD Medtronic - MITG
PRS Account Medtronic - MITG
Verification Date August 2014