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



Status:Enrolling by invitation
Healthy:No
Age Range:18 - 75
Updated:8/23/2018
Start Date:July 2016
End Date:December 2020

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

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).

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

Inclusion Criteria:

- Male or female , 18 to 75 years of age

- ASA I, II or III

- Capable and willing to consent

- Participants literate in English language

Exclusion Criteria:

- ASA IV or V

- Patients with severe visual or auditory disorder

- Illiteracy

- Chronic Obstructive Pulmonary Disease

- Restrictive Lung Diseases

- Benzodiazepines use

- Patients who were undergoing surgical procedures involving the upper airway, including
tonsillectomy, septoplasty, uvuloplasty, uvulopalatoplasty, uvulopharyngoplasty, or
uvulopalatopharyngoplasty, as these procedures were most likely to have been indicated
to cure the primary disease process (OSA)

- Cardiac surgeries

- Neurosurgeries (Brain)

- Any condition, which in the opinion of the investigator would make subject ineligible
for participation in the study such as history of unstable cardiovascular, pulmonary,
renal, hepatic, neurologic (seizures), hematologic or endocrine abnormality
(hyperthyroidism, unstable Diabetes type I/II)
We found this trial at
1
site
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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mi
from
Columbus, OH
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