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Oxygen Saturation Monitoring During Surgery

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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:
Information provided by (Responsible Party):
Medtronic - MITG

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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



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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01098851


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

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01098851     History of Changes
Other Study ID Numbers: COV-MO-PO-1000
First Posted: April 5, 2010    Key Record Dates
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