Protocol No: | ECCT/15/11/02 | Date of Protocol: | 24-07-2015 |
Study Title: | EFFECT OF LARYNGEAL MASK AIRWAY MANOMETRY ON POST OPERATIVE SORE THROAT IN SPONTANEOUSLY BREATHING ADULT PATIENTS PRESENTING FOR SURGERY AT AGA KHAN UNIVERSITY HOSPITAL, NAIROBI. |
Study Objectives: | |
Laymans Summary: | |
Abstract of Study: | ABSTRACT Background Laryngeal mask airways (LMAs) are widely used in surgery and are considered to be generally safe. Postoperative sore throat (POST) is a frequent complication following LMA use and can be very distressing to patients. The use of a laryngeal mask airway cuff pressure of between 23 and 24mmhg in alleviating postoperative sore throat has not been investigated. Primary objective • To determine the occurrence of POST between the intervention group in which LMA cuff pressures will be adjusted to 23-24mmhg and the control group in whom only monitoring of LMA cuff pressures will be done Secondary Objectives To compare the laryngeal mask airway pressures between the two study groups To determine the severity of postoperative sore throat between the two study groups Study Design: A single blind randomized control trial Methods A sample size of eighty patients will be used. This will include ASA 1 and ASA II patients scheduled to receive general anaesthesia with use of an LMA and are having elective surgery Intervention: Laryngeal mask airway cuff pressures will be adjusted in the intervention group by the principal investigator to a pressure of between 23 and 24mmhg.The none intervention group will only have LMA cuff pressures monitored. Data collection Patients will be interviewed at two, six and twelve hours postoperatively. Data of their baseline characteristics, occurrence and severity of POST will be collected. If POST is present, a Numerical Rating Scale (NRS) will be used to assess its severity. Cuff pressures in the two study groups will also be determined Data Analysis Data collected using questionnaires and will be keyed into an MS Excel database and analyzed using Stata Version 10. Occurrence of POST in both study arms will be presented as a proportion and reported together with the 95% confidence interval. The difference in means of cuff pressures in the study arms will be analyzed using the Student t-test. In the event that the cuff pressures do not meet the rules of normality, the Mann-Whitney non-parametric test will be applied. A p value of <0.05 will be considered statistically significant. |