Oxygen Saturation Monitoring During Surgery

Sleep Apnea, Obstructive Clinical Trial

Official title:

Saturation Pattern Detection Prevalence Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098851
• Other study ID #: COV-MO-PO-1000
• Status: Completed
• Phase: N/A
• First received: March 31, 2010
• Last updated: August 5, 2014
• Start date: July 2009
• Est. completion date: November 2009

Study information

• Verified date: August 2014
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	Avista Adventist Hospital	Louisville	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes