Incidence and Severity of Postoperative Sore Throat And Intubation Response by Using Different Devices for Endotracheal Intubation

Study Overview
=================
Brief Summary
-----------------
Postoperative sore throat (POST) is a common problem following the use of endotracheal intubation during general anaesthesia. It leads to dissatisfaction and discomfort after surgery and can delay a patient's return to normal routine activities. POST has been rated by patients as the eighth most adverse effect in the postoperative period. The incidence of sore throat after endotracheal intubation varies from 14.4-90%. Laryngoscopy and tracheal intubation also leads to hemodynamic stress response. The response can be deleterious in patient with or without cardiac disease. It is related to the degree of manipulation of the airway during endotracheal intubation and has been studied during intubation for some equipment used for endotracheal intubation

Official Title
-----------------
Incidence and Severity of Postoperative Sore Throat And Intubation Response by Using Different Devices for Endotracheal Intubation

Conditions
-----------------
Pharyngitis, Endotracheal Intubation, Pain

Intervention / Treatment
-----------------
* Device: Endotracheal intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: After signing of the informed consent, ASA physical status I and II Mallampati class 1& 2, BMI < 35, Undergoing elective surgical procedures (not exceeding two hours in duration) requiring ET intubation Exclusion Criteria: Patients undergoing day case, bariatric, cardiac, nasal, oral or head & neck surgeries, requiring placement of throat pack or nasogastric/ orogastric tube, patients assigned to rapid sequence induction, hoarseness, patients with anticipated difficult intubation, history of recent upper respiratory tract infection, history of difficult intubation psychiatric disorders hindering proper evaluation, use of steroids (oral or inhalational) or non-steroidal anti-inflammatory drugs within one week of surgery or previous surgery within last two weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glidescope<br> | Device: Endotracheal intubation<br>* Endotracheal intubation will be done with any of these equipments<br>|
| Active Comparator: Macintosh laryngoscope<br> | Device: Endotracheal intubation<br>* Endotracheal intubation will be done with any of these equipments<br>|
| Active Comparator: Bonfill's rigid scope<br> | Device: Endotracheal intubation<br>* Endotracheal intubation will be done with any of these equipments<br>|
| Active Comparator: Air traq<br> | Device: Endotracheal intubation<br>* Endotracheal intubation will be done with any of these equipments<br>|
| Active Comparator: C -Mac scope<br> | Device: Endotracheal intubation<br>* Endotracheal intubation will be done with any of these equipments<br>|
| Active Comparator: flexible fiberoptic scope<br> | Device: Endotracheal intubation<br>* Endotracheal intubation will be done with any of these equipments<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post operative sore throat |  | 0 hours after surgery | 
| Incidence of post operative sore throat |  | 6 hours after surgery | 
| Incidence of post operative sore throat |  | 12 hours after surgery | 
| Incidence of post operative sore throat |  | 24 hours after surgery | 
| Severity of post operative sore throat |  | 0 hours after surgery | 
| Severity of post operative sore throat |  | 6 hours after surgery | 
| Severity of post operative sore throat |  | 12 hours after surgery | 
| Severity of post operative sore throat |  | 24 hours after surgery | 
| Mean arterial pressure after endotracheal intubation |  | 1 minute after surgery | 
| Mean arterial pressure after endotracheal intubation |  | 2 minutes after surgery | 
| Mean arterial pressure after endotracheal intubation |  | 3 minutes after surgery | 
| Mean arterial pressure after endotracheal intubation |  | 4 minutes after surgery | 
| Mean arterial pressure after endotracheal intubation |  | 5 minutes after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cormack Leehanes grade of laryngeal view |  | At the time of intubation | 
| Percentage of glottic opening score (POGO) score |  | At the time of intubation | 
| Intubation difficulty score |  | At the time of intubation | 
| Patient's satisfaction score |  | After 24 hours of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Measurement