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Application of Nasal Cannula With Oxygen Versus Air During Eye Surgery Under Local Anaesthetic

Primary Purpose

Hypoxia, Hypercapnia

Status
Completed
Phase
Phase 1
Locations
Malaysia
Study Type
Interventional
Intervention
oxygen
oxygen
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypoxia focused on measuring hypoxia or hypercarbia during surgery under the drape

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • (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.

Exclusion Criteria:

  • pre-existing pulmonary diseases, Psychological disorders, Neurological disorders and patients required sedation.

Sites / Locations

  • University Malaya Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

oxygen

air supplement

Arm Description

Outcomes

Primary Outcome Measures

Evidence of desaturation during intraoperative period under the drape

Secondary Outcome Measures

Full Information

First Posted
July 5, 2010
Last Updated
August 15, 2011
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT01157624
Brief Title
Application of Nasal Cannula With Oxygen Versus Air During Eye Surgery Under Local Anaesthetic
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Malaya

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Surgery involvement the eye has widely been done under local anaesthesia provided by the ophthalmologists. Patients are often awake or mildly sedated during the surgery. However, due to the surgical drape which covers the patients face and beyond in order to maintain sterility of the surgical field, it may lead to hypoxia in these patients and retention of exhaled air within the confined space under the drape. This may lead to patient discomfort and the surgeon will face difficulty when the patient becomes restless and unable to be still for the surgery. Various studies had been conducted using nasal cannula with oxygen or air which is administered to patients having cataract surgery under local anaesthetics and the results has so far been inconclusive. One study evaluated the saturation of O2 in arterial blood, the partial pressure of O2 in arterial blood (PaO2), the partial pressure of CO2 in arterial blood (PaCO2) and the pH. The operative blood gas parameters were maintained in the air inhalation patients. Oxygen supplement caused significant increase in the saturation of O2 in arterial blood and in PaO2. There was no difference between the two groups in PaCO2. The pH of the arterial blood showed a statistically significant decrease in the patients with O2 supplement. This shift to more acidotic levels could cause central nervous system depression with reduced respiratory stimulus. Recommendation was to administer air rather than O2 to patients during cataract surgery.[1] Another clinical trials have shown that O2 application by nasal cannula prevents hypoxia but not rebreathing of CO2 in patients undergoing eye surgery under local anaesthetics.[4] In this clinical trial, we use Duo flow O2 + CO2 sampling cannula designed in a way to deliver O2 and sampling of expired CO2 gases from both nostril simultaneously. The aim of this study is to randomly administer O2 or air through a new nasal cannula to patients undergoing eye surgery under local anaesthetic and to evaluate the significance of O2 supplement and whether CO2 retention has an indirect effect to it.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Hypercapnia
Keywords
hypoxia or hypercarbia during surgery under the drape

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oxygen
Arm Type
Active Comparator
Arm Title
air supplement
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
oxygen
Other Intervention Name(s)
resuscitation for hypoxia
Intervention Description
Subjects who are found to desaturate during treatment with air will be supplement with oxygen
Intervention Type
Drug
Intervention Name(s)
oxygen
Other Intervention Name(s)
resuscitation for hypoxia
Intervention Description
Subjects who are found to desaturate during treatment with air will be supplement with oxygen
Primary Outcome Measure Information:
Title
Evidence of desaturation during intraoperative period under the drape
Time Frame
Intraoperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: (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. Exclusion Criteria: pre-existing pulmonary diseases, Psychological disorders, Neurological disorders and patients required sedation.
Facility Information:
Facility Name
University Malaya Medical Center
City
Kuala Lumpur
State/Province
Federal Teritory
ZIP/Postal Code
59100
Country
Malaysia

12. IPD Sharing Statement

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Application of Nasal Cannula With Oxygen Versus Air During Eye Surgery Under Local Anaesthetic

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