Oxygen Saturation Monitoring During Surgery

NCT01098851 | Completed Results

• 1 other identifier: COV-MO-PO-1000
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with Obstructive Sleep Apnea (OSA) have cyclical patterns of lower blood oxygen during sleep because of repeated episodes of upper airway obstruction that cause their breathing to stop. When these patients have surgery, anesthetic drugs may worsen these patterns of lower blood oxygen. This study monitors ten patients at high risk for OSA and ten patients at low risk for OSA during surgery. Patterns of lower oxygen saturations should arise in the high risk group but not the low risk group.

Conditions

Sleep Apnea, Obstructive

Keywords

Obstructive Sleep Apnea; Pulse Oximetry

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow

  Saturation Pattern Detection (SPD) is the pattern of oxygen saturation values plotted against time that occurs when patients have cyclical reduced air movement during breathing. Their blood oxygen level decreases and increases as they slow and increase their breathing.

  3 hours

• Number of Participants Requiring Airway Support

  Drugs during surgery may cause the throat to relax and block breathing. To treat this, the caregiver administers airway support. Airway support is moving the jaw forward, inserting a plastic tube (nasal-oral airway) or applying a mask with positive pressure.

  3 hours

Study Arms (2)

Obstructive Sleep Apnea

Surgery patients at high risk for Obstructive Sleep Apnea

Surgery Patients

Surgery patients at low risk for Obstructive Sleep Apnea

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care hospital

You may qualify if:

• Age greater than 21 years
• Patients scheduled for a procedure that requires analgesia and/or sedation by any route (intravenous, intramuscular, oral, epidural or intrathecal).
• Patients with an anticipated length of sedation greater than or equal to one hour.
• Patients in the ASA category I through III.
• Patients who only receive propofol, benzodiazepines, and opioids.

You may not qualify if:

• Age less than 21 years
• Patients whose room air oxygen saturation is \<90%
• Patients receiving post-operative positive airway pressure support
• Previous allergic/contact reactions to adhesives
• CHF
• Moderate or severe valvular disease
• TIA/CVA
• Carotid stenosis or endarterectomy
• Anemia (HCT if available \< 30%)
• Pulmonary hypertension
• Dialysis
• Pregnancy
• Patients unable to give informed consent

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Avista Adventist Hospital

Louisville, Colorado, 80027, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

Small numbers of subjects analyzed.

Results Point of Contact

• Title: Fran Haury
• Organization: Covidien

fran.haury@covidien.com

303 305-2314

Study Officials

• Roger Mecca, MD

  Medtronic - MITG

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: April 5, 2010
• Study Start: July 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: August 7, 2014
• Results First Posted: June 29, 2011

Record last verified: 2014-08

Locations

US (1)