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Rates of Apnea in Patients Undergoing Vitreoretinal Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theodore Leng, Stanford University
ClinicalTrials.gov Identifier:
NCT01745341
First received: December 5, 2012
Last updated: November 17, 2014
Last verified: November 2014
  Purpose

The purpose of this study is to determine if apnea (the stopping of breathing) occurs in patients undergoing undergoing monitored anesthesia care (MAC) for vitreoretinal surgery


Condition
Apnea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rates of Apnea in Patients Undergoing Vitreoretinal Surgery

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Apnea [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Determine if patients undergoing vitreoretinal surgery under monitored anesthesia care stop breathing during the procedure


Enrollment: 113
Study Start Date: August 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
vitreoretinal surgery patients
Patients undergoing vitreoretinal surgery under monitored anesthesia care. They will be observed during surgery and no interventions will be administered.

Detailed Description:

Patients undergoing vitreoretinal surgery will be monitored during the procedure to determine if they stop breathing. This study is observational in nature and no interventions will be made.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients having vitreoretinal surgery under monitored anesthesia care

Criteria

Inclusion Criteria:

  • patients having vitreoretinal surgery under monitored anesthesia care

Exclusion Criteria:

  • patients having vitreoretinal surgery without monitored anesthesia care
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745341

Locations
United States, California
Stanford Hospital and Clinics
Palo Alto, California, United States, 94303
Sponsors and Collaborators
Stanford University
  More Information

No publications provided

Responsible Party: Theodore Leng, Clinical Assistant Professor of Ophthalmology, Stanford University
ClinicalTrials.gov Identifier: NCT01745341     History of Changes
Other Study ID Numbers: 25284
Study First Received: December 5, 2012
Last Updated: November 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on November 20, 2014