Oxygen Saturation Monitoring During Surgery

• ClinicalTrials.gov Identifier: NCT01098851
• Recruitment Status: Completed
• First Posted: April 5, 2010
• Results First Posted: June 29, 2011
• Last Update Posted: August 7, 2014
• Sponsor: Medtronic - MITG
• Information provided by (Responsible Party): Medtronic - MITG

Study Description

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.

Condition or disease
Sleep Apnea, Obstructive

Detailed Description:

Patients with Obstructive Sleep Apnea (OSA) have episodes of upper airway obstruction during sleep which have been shown to be accompanied by multiple oxygen desaturations followed by short recovery intervals until rising PaCO2 causes sleep disruption/rescue arousal. In the postoperative and conscious sedation arena, these patterns can deteriorate from a stable pattern to a severely unstable pattern which may go unrecognized and lead to an adverse event (respiratory/cardiac arrest; death).

Anesthesia and the higher consumption of analgesics produce a profound reduction in pharyngeal tone, a dampening of both chemoreceptor sensitivity and arousal/rescue response. Thus the first 48 hours post operatively presents a vulnerable period. Respiratory disturbances are more prominent - respiratory arrest and hypopnea being the main adverse occurrences during this period.

An algorithm has been developed that monitors saturation and indicates repetitive reductions in airflow through the upper airway and into the lungs. Presence of this pattern in the procedural sedation patient population has not been tested for its prevalence. This study will monitor patients during surgery to determine if this pattern occurs in this hospital setting.

Study Design

• Study Type: Observational
• Actual Enrollment: 21 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Saturation Pattern Detection Prevalence Study Protocol
• Study Start Date: July 2009
• Actual Primary Completion Date: November 2009
• Actual Study Completion Date: November 2009

Groups and Cohorts

Group/Cohort
Obstructive Sleep Apnea; Surgery patients at high risk for Obstructive Sleep Apnea
Surgery Patients; Surgery patients at low risk for Obstructive Sleep Apnea

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow [ Time Frame: 3 hours ]
   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.
2. Number of Participants Requiring Airway Support [ Time Frame: 3 hours ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Primary care hospital

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Contacts and Locations

Locations

United States, Colorado

Avista Adventist Hospital

Louisville, Colorado, United States, 80027

Sponsors and Collaborators

Medtronic - MITG

Investigators

• Study Chair: Roger Mecca, MD; Medtronic - MITG

More Information

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT01098851
• Other Study ID Numbers: COV-MO-PO-1000
• First Posted: April 5, 2010
• Results First Posted: June 29, 2011
• Last Update Posted: August 7, 2014
• Last Verified: August 2014

Keywords provided by Medtronic - MITG:

Obstructive Sleep Apnea; Pulse Oximetry

Additional relevant MeSH terms:

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