Sleep Disordered Breathing
Conditions
Keywords
Post Op Patients, Continuous Pulse Oximetry Monitoring, Major Surgery
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.
Interventions
DEVICEOxygen Monitoring
No intervention
Sponsors
Medtronic - MITG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AE) Caused by no Breathing | 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 |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from February 12, 2010 to June 25, 2010 from an acute care hospital.
Pre-assignment details
All enrolled patients were included into the trial. This was an observational study.
Participants by arm
| Arm | Count |
|---|---|
| Major Surgery Post Operative patients | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Major Surgery |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 45 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants |
| Age, Continuous | 63.79 years STANDARD_DEVIATION 12.018 |
| Region of Enrollment United States | 100 participants |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
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.
Time frame: 5 days
Population: 93 evaluable patients out of 100 enrolled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| General Care Floor | Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert. | 74 participants |
Secondary
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
Time frame: Five Nights
Population: All enrolled patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| General Care Floor | Number of Participants With Adverse Events (AE) Caused by no Breathing | 0 participants |