Application of Nasal Cannula With Oxygen Versus Air During Eye Surgery Under Local Anaesthetic
1 other identifier
interventional
100
1 country
1
Brief Summary
The investigators hypothesize that this new nasal cannula will prevent lack of oxygen as well as reduce rebreathing of carbon dioxide under ophthalmic drapes during eye surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 5, 2010
CompletedFirst Posted
Study publicly available on registry
July 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedAugust 17, 2011
August 1, 2011
5 months
July 5, 2010
August 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evidence of desaturation during intraoperative period under the drape
Intraoperative period
Study Arms (2)
oxygen
ACTIVE COMPARATORair supplement
PLACEBO COMPARATORInterventions
Subjects who are found to desaturate during treatment with air will be supplement with oxygen
Eligibility Criteria
You may qualify if:
- (ASA) physical status I, II or III, adult age 40-80 years old group, scheduled to undergo elective eye surgery under local anaesthetic at UMMC will be enrolled in this study.
You may not qualify if:
- pre-existing pulmonary diseases, Psychological disorders, Neurological disorders and patients required sedation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Malaya Medical Center
Kuala Lumpur, Federal Teritory, 59100, Malaysia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 5, 2010
First Posted
July 7, 2010
Study Start
May 1, 2010
Primary Completion
October 1, 2010
Study Completion
December 1, 2010
Last Updated
August 17, 2011
Record last verified: 2011-08