Oxygen Monitoring of Patients After Surgery on the Hospital General Care Floor

• 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: Medtronic - MITG
• 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

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

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