NCT02729077

Risk Factors for Post-Operative Respiratory Complications in Patients at Risk for OSA

PERIOPERATIVE RISK FACTORS FOR POSTOPERATIVE RESPIRATORY COMPLICATIONS IN PATIENTS AT RISK FOR OBSTRUCTIVE SLEEP APNEA

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 324 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study investigates the incidence of postoperative respiratory complications (PRCs) including: oxygen desaturation events, tracheal re-intubations within 48 hours of surgery, and failure to wean from ventilator within 48 hours of surgery - in patients with and without risk factors for OSA undergoing elective, non-cardiac surgery (NCS).

Detailed description

324 subjects will be enrolled into one of two groups: increased or not increased risk for OSA, n=162 patients per group. Preoperative assessments of OSA status, Mallampati score (an assessment for mouth and throat morphology), STOP-BANG test (assessment for risk of OSA), and medical history will be used to determine patient group assignment. All subjects will receive standard general anesthesia and monitoring as a part of standard of care whether or not she/he will participate in the study, including ECG, arterial pressure, SpO2, BIS, Blood pressure (BP), heart rate (HR), and respiratory rate (RR), all of which will be continuously recorded and data will be saved for every three minutes during induction using standard monitors. Standard monitoring assessments in PACU will be used, and patients with increased perioperative risk for OSA will be closely monitored for hypoxemia and other complications. The Nellcor Pulse Oximetry Sensor will be applied in PACU and continuously monitor the patient's oxygen saturation and respiratory rate for the first 48 hours postoperatively. At the end of the 48 hours, the device will be removed, and the de-identified data will be transferred to a computer with analysis software and examined for patterns in respiratory distress in both patient groups. Data collected from the Nellcor Bedside Respiratory Patient Monitoring System on pulse and oxygen saturation, as well as data on clinically significant events, such as PRCs, acute respiratory failure, tracheal reintubation, hypoxemia, CHF, MI, A-fib, and delirium will be analyzed to understand the effects of OSA on postoperative recovery

Conditions

• Respiratory Complications

Interventions

Type	Name	Description
DEVICE	Pulse Oximetry	Use of pulse oximetry device for 48 hours after surgery.

Timeline

• Start date: 2016-07-01
• Primary completion: 2021-02-04
• Completion: 2021-02-04
• First posted: 2016-04-06
• Last updated: 2021-02-24

Locations

1 site across 1 country: United States