Hoarseness of VoiceNCT05531617
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
A study testing Intubation in people with Hoarseness of Voice and Sore-throat, run by Seth Gordhandas Sunderdas Medical College at 1 site in India.
Trial summary
The aim of this study is to compare the incidence of postoperative sore throat after intubation with two different types of laryngoscopes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hoarseness of Voice, Sore-throat
- What is being tested?
- Intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2019to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Patients refusing to give consent
- Pregnant and lactating patients
- Patients with severe co-morbidities requiring postoperative ventilatory support
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare the incidence of postoperative sore throat after intubation with two different types of laryngoscopes.
Read the 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 .
- Conditions
- Hoarseness of Voice, Sore-throat
- Being tested
- Intubation
- Keywords
- Endotracheal tube, Postoperative sore throat, Hoarseness of voice, Macintosh laryngoscope, C-MAC video laryngoscope
- Medical subject headings
- Hoarseness, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntubationProcedure or surgery
Study groups Intubated with Macintosh or cmac video laryngoscopes
| Study group | Role | What they receive |
|---|---|---|
| M group | Active comparator | Group Intubated with Macintosh laryngoscope is labelled as M group Receives: Procedure: Intubation |
| V group | Active comparator | Group Intubated with C-Mac video laryngoscope is labelled as V group Receives: Procedure: Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Upto 24 hours after surgery
Secondary outcomes (1)
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
Measured: Upto 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start1 Jan 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hoarseness of VoiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective,randomised, open label study
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seth Gordhandas Sunderdas Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gousmahammad Myageri, Seth Gordhandas Sunderdas Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531617
- Sponsor's protocol ID
- EC/202/2018
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29628570Aqil 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.
PubMed 28899338
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05531617
- Acronym / sponsor ID
- EC/202/2018
- Conditions
- Hoarseness of Voice, Sore-throat
- Keywords
- Endotracheal tube, Postoperative sore throat, Hoarseness of voice, Macintosh laryngoscope, C-MAC video laryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Seth Gordhandas Sunderdas Medical CollegeUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective,randomised, open label study
| Arm | Type | Receives |
|---|---|---|
| M group | Active comparator | Procedure: IntubationGroup Intubated with Macintosh laryngoscope is labelled as M group |
| V group | Active comparator | Procedure: IntubationGroup Intubated with C-Mac video laryngoscope is labelled as V group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Patients refusing to give consent
- Pregnant and lactating patients
- Patients with severe co-morbidities requiring postoperative ventilatory support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IntubationStudy groups Intubated with Macintosh or cmac video laryngoscopes | Procedure or surgery | M group, V group |
Primary outcome
The incidence and severity of postoperative sore throat measured
Time frame: Upto 24 hours after surgery
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
1 secondary outcome
The incidence and severity of Hoarseness of voice
Time frame: Upto 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Background: PubMed 29628570Tosh 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.
- Background: PubMed 28899338Aqil 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation in people with Hoarseness of Voice and Sore-throat, run by Seth Gordhandas Sunderdas Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of postoperative sore throat measured (time frame: Upto 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05531617, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.