N/A
N=100
Oxygen Monitoring of Patients After Surgery on the Hospital General Care Floor
Sleep Disordered Breathing
Bottom Line
View on ClinicalTrials.gov: NCT01082575 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert. — 74 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Oxygen Monitoring (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert. |
74 | — |
| SECONDARY Number of Participants With Adverse Events (AE) Caused by no Breathing |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01082575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.