NCT01157624

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

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2010

Shorter than P25 for phase_1

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

May 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 17, 2011

Status Verified

August 1, 2011

Enrollment Period

5 months

First QC Date

July 5, 2010

Last Update Submit

August 15, 2011

Conditions

Keywords

hypoxia or hypercarbia during surgery under the drape

Outcome Measures

Primary Outcomes (1)

  • Evidence of desaturation during intraoperative period under the drape

    Intraoperative period

Study Arms (2)

oxygen

ACTIVE COMPARATOR
Drug: oxygen

air supplement

PLACEBO COMPARATOR
Drug: oxygen

Interventions

oxygenDRUG

Subjects who are found to desaturate during treatment with air will be supplement with oxygen

Also known as: resuscitation for hypoxia
oxygen

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

HypoxiaHypercapnia

Interventions

OxygenResuscitation

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGasesEmergency TreatmentTherapeutics

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

Locations