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

• ClinicalTrials.gov Identifier: NCT02729077
• Recruitment Status: Unknown
• First Posted: April 6, 2016
• Last Update Posted: August 21, 2018
• Sponsor: Ohio State University
• Collaborator: Medtronic - MITG
• Information provided by (Responsible Party): Nicoleta Stoicea, Ohio State University

Study Description

Brief 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).

Condition or disease	Intervention/treatment
Respiratory Complications	Device: Pulse Oximetry

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

Study Design

• Study Type: Observational
• Estimated Enrollment: 324 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: PERIOPERATIVE RISK FACTORS FOR POSTOPERATIVE RESPIRATORY COMPLICATIONS IN PATIENTS AT RISK FOR OBSTRUCTIVE SLEEP APNEA
• Study Start Date: July 2016
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: December 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
Increased risk for OSA; Vital signs including oxygen saturation, respiratory rate, ECG, arterial pressure, BIS, blood pressure, heart rate will be monitored and hypoxemia will be measured during anesthetic care, and oxygen saturation and respiratory rate will be measured for 48 hours after surgery with pulse oximetry. Patients in this arm will be especially evaluated for hypoxemia and other complications.	Device: Pulse Oximetry; Use of pulse oximetry device for 48 hours after surgery.
Not increased risk for OSA; Vital signs including oxygen saturation, respiratory rate, ECG, arterial pressure, BIS, blood pressure, heart rate will be monitored and hypoxemia will be measured during anesthetic care, and oxygen saturation and respiratory rate will be measured for 48 hours after surgery with pulse oximetry.	Device: Pulse Oximetry; Use of pulse oximetry device for 48 hours after surgery.

Outcome Measures

Primary Outcome Measures :

1. incidence of postoperative respiratory complications (PRCs) based on cumulative minutes per 24 hours of oxygen desaturation events ≤ 90% [ Time Frame: 24 hours ]
   Identify respiratory complications such as hypoxemia, respiratory failure requiring assisted ventilation, and reintubation, every 24 hours

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Adult patients at Ohio State University Wexner Medical Center, aged between 18-75 years, with an American Society of Anesthesiologists (ASA) physical status of I (normal healthy patient), II (patients with mild systemic disease; no functional limitation) or III (patient with severe systemic disease; definite functional impairment - with relatively stable disease, but requiring therapy) who are scheduled to undergo elective surgeries under sevoflurane general anesthesia as a standard of care.

Criteria

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)

Contacts and Locations

Locations

United States, Ohio

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Ohio State University

Medtronic - MITG

Investigators

• Principal Investigator: Nicoleta Stoicea, MD, PhD; The Ohio State University Wexner Medical Center

More Information

• Responsible Party: Nicoleta Stoicea, Principal Investigator, Ohio State University
• ClinicalTrials.gov Identifier: NCT02729077
• Other Study ID Numbers: 2015H0052
• First Posted: April 6, 2016
• Last Update Posted: August 21, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No