A Prospective,Randomised, Open Label Study for Comparison of the Incidence and Severity of Postoperative Sore Throat (POST) Using C-MAC Video Laryngoscope and Traditional Macintosh Laryngoscope for Intubation
Primary Purpose
Hoarseness of Voice, Sore-throat
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Intubation
Sponsored by
About this trial
This is an interventional screening trial for Hoarseness of Voice focused on measuring Endotracheal tube, Postoperative sore throat, Hoarseness of voice, Macintosh laryngoscope, C-MAC video laryngoscope
Eligibility Criteria
Inclusion Criteria:
- Age more than 18 years
- American society of Anaesthesiologists(ASA)1 and 2
- Mallampati (MPC) grading 1 and 2
- laparoscopic cholecystectomy and appendectomy
- Surgeries of short duration(<2hour)
Exclusion Criteria:
- Patients refusing to give consent
- Pregnant and lactating patients
- Patients with severe co-morbidities requiring postoperative ventilatory support
Sites / Locations
- Seth GSMC and KEM Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
M group
V group
Arm Description
Group Intubated with Macintosh laryngoscope is labelled as M group
Group Intubated with C-Mac video laryngoscope is labelled as V group
Outcomes
Primary Outcome Measures
The incidence and severity of postoperative sore throat measured
The incidence and severity of Postoperative sore throat is measured after surgery at 2hours, 6hours, 12hours and 24 hours based on a scaling system as described below
No sore throat at any time since the operation Grade 0
Minimal - patient answered in the affirmative when asked about sore throat - Grade1
Moderate - patient complained of sore throat on his/her own - Grade 2
Severe - patient is in obvious distress-Grade 3
Secondary Outcome Measures
The incidence and severity of Hoarseness of voice
The incidence and severity of Postoperative hoarseness of voice measured at 2hours, 6hours, 12hours and 24hours post surgery by scaling system as described below
No complaint of hoarseness at any time since the operation - Grade 0
Minimal - minimal change in quality of speech. Patient answers in the affirmative only when enquired about - Grade 1
Moderate - moderate change in quality of speech of which the patient complains on his/her own - Grade 2
Severe - gross change in the quality of voice perceived by the observer - Grade 3
Full Information
NCT ID
NCT05531617
First Posted
September 1, 2022
Last Updated
September 2, 2022
Sponsor
Seth Gordhandas Sunderdas Medical College
1. Study Identification
Unique Protocol Identification Number
NCT05531617
Brief Title
A Prospective,Randomised, Open Label Study for Comparison of the Incidence and Severity of Postoperative Sore Throat (POST) Using C-MAC Video Laryngoscope and Traditional Macintosh Laryngoscope for Intubation
Official Title
A Prospective,Randomised, Open Label Study for Comparison of the Incidence and Severity of Postoperative Sore Throat (POST) Using C-MAC Video Laryngoscope and Traditional Macintosh Laryngoscope for Intubation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seth Gordhandas Sunderdas Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to compare the incidence of postoperative sore throat after intubation with two different types of laryngoscopes.
Detailed Description
Postoperative sore throat is a well known complication after endotracheal intubation. One of the major contributing factors is trauma associated with laryngoscopy. With decreased force applied to visualise cords, video laryngoscopes should decrease the incidence of postoperative sore throat. In this study we compared the incidence and severity of postoperative sore throat when laryngoscopy was done using c-mac video laryngoscope D-blade( group V) versus Macintosh laryngoscope (Group M). Method: Fifty four American society of Anaesthesiologists (ASA) 1&2 patients between age 18-60 years , undergoing laproscopic surgeries of short duration were included in this study and laryngoscopy was done with Macintosh laryngoscope in M group and with C MAC video laryngoscope D blade in V group. Patients were followed up 2hours, 6hours, 12hours and 24hours in postoperative period to see postoperative sore throat and hoarseness of voice .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hoarseness of Voice, Sore-throat
Keywords
Endotracheal tube, Postoperative sore throat, Hoarseness of voice, Macintosh laryngoscope, C-MAC video laryngoscope
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective,randomised, open label study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
M group
Arm Type
Active Comparator
Arm Description
Group Intubated with Macintosh laryngoscope is labelled as M group
Arm Title
V group
Arm Type
Active Comparator
Arm Description
Group Intubated with C-Mac video laryngoscope is labelled as V group
Intervention Type
Procedure
Intervention Name(s)
Intubation
Intervention Description
Study groups Intubated with Macintosh or cmac video laryngoscopes
Primary Outcome Measure Information:
Title
The incidence and severity of postoperative sore throat measured
Description
The incidence and severity of Postoperative sore throat is measured after surgery at 2hours, 6hours, 12hours and 24 hours based on a scaling system as described below
No sore throat at any time since the operation Grade 0
Minimal - patient answered in the affirmative when asked about sore throat - Grade1
Moderate - patient complained of sore throat on his/her own - Grade 2
Severe - patient is in obvious distress-Grade 3
Time Frame
Upto 24 hours after surgery
Secondary Outcome Measure Information:
Title
The incidence and severity of Hoarseness of voice
Description
The incidence and severity of Postoperative hoarseness of voice measured at 2hours, 6hours, 12hours and 24hours post surgery by scaling system as described below
No complaint of hoarseness at any time since the operation - Grade 0
Minimal - minimal change in quality of speech. Patient answers in the affirmative only when enquired about - Grade 1
Moderate - moderate change in quality of speech of which the patient complains on his/her own - Grade 2
Severe - gross change in the quality of voice perceived by the observer - Grade 3
Time Frame
Upto 24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age more than 18 years
American society of Anaesthesiologists(ASA)1 and 2
Mallampati (MPC) grading 1 and 2
laparoscopic cholecystectomy and appendectomy
Surgeries of short duration(<2hour)
Exclusion Criteria:
Patients refusing to give consent
Pregnant and lactating patients
Patients with severe co-morbidities requiring postoperative ventilatory support
Facility Information:
Facility Name
Seth GSMC and KEM Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29628570
Citation
Tosh P, Kadapamannil D, Rajan S, Narayani N, Kumar L. Effect of C-MAC Video Laryngoscope-aided intubations Using D-Blade on Incidence and Severity of Postoperative Sore Throat. Anesth Essays Res. 2018 Jan-Mar;12(1):140-144. doi: 10.4103/aer.AER_182_17.
Results Reference
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PubMed Identifier
28899338
Citation
Aqil M, Khan MU, Mansoor S, Mansoor S, Khokhar RS, Narejo AS. Incidence and severity of postoperative sore throat: a randomized comparison of Glidescope with Macintosh laryngoscope. BMC Anesthesiol. 2017 Sep 12;17(1):127. doi: 10.1186/s12871-017-0421-4. Erratum In: BMC Anesthesiol. 2018 Aug 17;18(1):112.
Results Reference
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A Prospective,Randomised, Open Label Study for Comparison of the Incidence and Severity of Postoperative Sore Throat (POST) Using C-MAC Video Laryngoscope and Traditional Macintosh Laryngoscope for Intubation
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