NCT01745341

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

1 year

First QC Date

December 5, 2012

Last Update Submit

December 2, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Apnea

    Determine if patients undergoing vitreoretinal surgery under monitored anesthesia care stop breathing during the procedure

    15 minutes

Study Arms (1)

vitreoretinal surgery patients

Patients undergoing vitreoretinal surgery under monitored anesthesia care. They will be observed during surgery and no interventions will be administered.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients having vitreoretinal surgery under monitored anesthesia care

You may qualify if:

  • patients having vitreoretinal surgery under monitored anesthesia care

You may not qualify if:

  • patients having vitreoretinal surgery without monitored anesthesia care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Hospital and Clinics

Palo Alto, California, 94303, United States

Location

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor of Ophthalmology

Study Record Dates

First Submitted

December 5, 2012

First Posted

December 10, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations