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

This study has been completed.

Sponsor:

Information provided by:

University of Malaya

ClinicalTrials.gov Identifier:

NCT01157624

First received: July 5, 2010

Last updated: August 15, 2011

Last verified: August 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	July 5, 2010
Last Updated Date	August 15, 2011
Start Date ^ICMJE	May 2010
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 6, 2010)	Evidence of desaturation during intraoperative period under the drape [ Time Frame: Intraoperative period ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01157624 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Application of Nasal Cannula With Oxygen Versus Air During Eye Surgery Under Local Anaesthetic
Official Title ^ICMJE	Not Provided
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Health Services Research
Condition ^ICMJE	Hypoxia Hypercapnia
Intervention ^ICMJE	Drug: oxygen Subjects who are found to desaturate during treatment with air will be supplement with oxygen Other Name: resuscitation for hypoxia
Study Arm (s)	Active Comparator: oxygen Intervention: Drug: oxygen Placebo Comparator: air supplement Intervention: Drug: oxygen
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	100
Completion Date	December 2010
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	40 Years to 80 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Malaysia

Administrative Information
NCT Number ^ICMJE	NCT01157624
Other Study ID Numbers ^ICMJE	nasalo2
Has Data Monitoring Committee	Yes
Responsible Party	Tan Siaw Boon, Department of Anaesthesiology, University Malaya
Study Sponsor ^ICMJE	University of Malaya
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Malaya
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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