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

NCT02729077 | Completed

• 1 other identifier: 2015H0052
• Study Type: observational
• Target: 324
• Locations: 1 country
• Sites: 1

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).

Conditions

Respiratory Complications

Outcome Measures

Primary Outcomes (1)

• incidence of postoperative respiratory complications (PRCs) based on cumulative minutes per 24 hours of oxygen desaturation events ≤ 90%

  Identify respiratory complications such as hypoxemia, respiratory failure requiring assisted ventilation, and reintubation, every 24 hours

  24 hours

Study Arms (2)

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

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

Interventions

Pulse Oximetry DEVICE

Use of pulse oximetry device for 48 hours after surgery.

Increased risk for OSA; Not increased risk for OSA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male or female , 18 to 75 years of age
• ASA I, II or III
• Capable and willing to consent
• Participants literate in English language

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ohio State University: lead
• Medtronic - MITG: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Interventions

Oximetry

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Nicoleta Stoicea, MD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 6, 2016
• Study Start: July 1, 2016
• Primary Completion: February 4, 2021
• Study Completion: February 4, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)