Trial Outcomes & Findings for Oxygen Monitoring of Patients After Surgery on the Hospital General Care Floor (NCT NCT01082575)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

100 participants

Primary outcome timeframe

5 days

Results posted on

2014-08-07

Participant Flow

Patients were recruited from February 12, 2010 to June 25, 2010 from an acute care hospital.

All enrolled patients were included into the trial. This was an observational study.

Participant milestones

Participant milestones
Measure	Major Surgery Post Operative patients
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Major Surgery n=100 Participants Post Operative patients
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=5 Participants
Age, Categorical >=65 years	45 Participants n=5 Participants
Age, Continuous	63.79 years STANDARD_DEVIATION 12.018 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days

Population: 93 evaluable patients out of 100 enrolled.

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.

Outcome measures

Outcome measures
Measure	General Care Floor n=93 Participants Observational General Care Floor Group
Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert.	74 participants

SECONDARY outcome

Timeframe: Five Nights

Population: All enrolled patients

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

Outcome measures

Outcome measures
Measure	General Care Floor n=100 Participants Observational General Care Floor Group
Number of Participants With Adverse Events (AE) Caused by no Breathing	0 participants

Adverse Events

Major Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Fran Haury Clinical Program Manager II

Covidien

Phone: 303 305-2314

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place