A Phase 1 interventional study of oxygen and oxygen in Hypoxia and Hypercapnia, sponsored by University of Malaya. Completed at 1 site in Malaysia. Open to participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-17.
Sponsored by University of Malaya · Phase 1, Interventional, and Health services research
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.
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.
1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.
This study's enrollment of 100 is above the median of 45 across 853 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →University of Malaya is the lead sponsor of 280 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Drug: oxygen
Drug: oxygen
Subjects who are found to desaturate during treatment with air will be supplement with oxygen
Also known as: resuscitation for hypoxia
Subjects who are found to desaturate during treatment with air will be supplement with oxygen
Also known as: resuscitation for hypoxia
Evidence of desaturation during intraoperative period under the drape
Time frame: Intraoperative period
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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University of Malaya