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Oxygen Saturation Monitoring During Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date March 31, 2010
First Posted Date April 5, 2010
Results First Submitted Date December 16, 2010
Results First Posted Date June 29, 2011
Last Update Posted Date August 7, 2014
Study Start Date July 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2011)
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: April 2, 2010)
Saturation Pattern Detection (SPD) [ Time Frame: 24 hours ]
Patients undergoing moderate to deep sedation will have SpO2 patterns consistent with repetitive reductions in airflow (RRAF).Our primary hypothesis is that patients undergoing moderate to deep sedation will have SpO2 patterns consistent with repetitive reductions in airflow (RRAF) and these patterns are more frequent/severe in patients at risk for OSA (STOP-BANG positive).
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Oxygen Saturation Monitoring During Surgery
Official Title Saturation Pattern Detection Prevalence Study Protocol
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.
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
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary care hospital
Condition Sleep Apnea, Obstructive
Intervention Not Provided
Study Groups/Cohorts
  • Obstructive Sleep Apnea
    Surgery patients at high risk for Obstructive Sleep Apnea
  • Surgery Patients
    Surgery patients at low risk for Obstructive Sleep Apnea
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 2, 2010)
21
Original Actual Enrollment Same as current
Actual Study Completion Date November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01098851
Other Study ID Numbers COV-MO-PO-1000
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medtronic - MITG
Study Sponsor Medtronic - MITG
Collaborators Not Provided
Investigators
Study Chair: Roger Mecca, MD Medtronic - MITG
PRS Account Medtronic - MITG
Verification Date August 2014