Oxygen Saturation Patterns in Post-Op Patients at Risk for Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01078207
First received: February 26, 2010
Last updated: August 5, 2014
Last verified: August 2014

February 26, 2010
August 5, 2014
January 2010
October 2010   (final data collection date for primary outcome measure)
Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data. [ Time Frame: 12 hour after released from the recovery room ] [ Designated as safety issue: No ]
Number of patients exhibiting the presence of repetitive reductions in airflow patterns in the pulse oximetry trend data collected on subjects
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Complete list of historical versions of study NCT01078207 on ClinicalTrials.gov Archive Site
Relationship Between the Oxygen Desaturation Patterns and Repetitive Reductions in Nasal Airflow as Measured by Inductance Plethysmography and Nasal Pressure. [ Time Frame: 12 hours after discharge form the recovery room ] [ Designated as safety issue: No ]
The number of patients with a positive repetitive reduction in nasal airflow which correlates with positive oxygen desaturation pattern as measured by photoplethysmography sensors.
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Oxygen Saturation Patterns in Post-Op Patients at Risk for Obstructive Sleep Apnea
A Prospective Non-Randomized Study of Pulse Oximetry Saturation Patterns in Postoperative Patients at High Risk of Obstructive Sleep Apnea

This study will include patients who have major surgery and are at risk for or have been diagnosed with sleep apnea. The patients will be monitored the night after surgery for repeating episodes of reduced breathing and oxygen levels. The study will determine if episodes of decreased breathing are reflected in the oxygen monitor.

There is no further detailed description available.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Patients older than 18 years undergoing thoracic, vascular, head and neck, gynecological, urological, general, orthopedic, and plastic surgery.

Obstructive Sleep Apnea
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients older than 18 years undergoing thoracic, vascular, head and neck, gynecological, urological, general, orthopedic, and plastic surgery.
  • Patient must require analgesia and/or sedation postoperatively by any route (intravenous, intramuscular, oral, epidural or intrathecal) for the duration of the study
  • Postoperative patients with at least one anticipated over night stay on the general ward with a minimum length of 14 hrs.
  • Patients in the ASA category 1-4
  • Patients at high risk for obstructive sleep apnea (OSA) as identified by the STOP-Bang Questionnaire or patients previously diagnosed with OSA and not using a CPAP device. (No screening with STOP needed for these patients.)
  • Spontaneous breathing

Exclusion Criteria:

  • Age less than 18 years
  • Patients receiving or anticipated to receive postoperative positive airway pressure support
  • Previous allergic/contact reactions to adhesives
  • Patients unable to give informed consent
  • Pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01078207
COV-MO-PO-A105
Yes
Covidien
Covidien
Not Provided
Study Chair: Roger Mecca, MD Covidien
Covidien
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP