Postoperative Sore ThroatNCT06218836
Effect of Inflated Versus Non-inflated Endotracheal Tube on Sore Throat
A study testing Pre-inflated endotracheal tube and Non-inflated endotracheal tube in people with Postoperative Sore Throat, run by Sir Ganga Ram Hospital at 1 site in India.
Trial summary
Postoperative sore throat (POST) is a common morbidity following upper airway access-control with direct laryngoscopy-intubation (DLI) technique. Various reasons (size of the tracheal tube, cuff pressure, rough tube pass, and reattempts, among others) have been cited and management strategies (pharmacologic: applying… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Sore Throat
- What is being tested?
- Pre-inflated endotracheal tube and Non-inflated endotracheal tube
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteIndia
- Study dates
- 23 Jan 2024to 21 Jul 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I and II
- Patients with anticipated non-difficult airway with the following characteristics:
- Normal head and neck movements ii. Adequate mouth opening iii. No retrognathia or prognathia iv. Normal dentition
- Surgeries with anticipated duration of 40 minutes - 3 hours
Who cannot join
- Obese patients (BMI > 33 kg/m2)
- Requiring use of intubation aids such as bougie, stylet or video-laryngoscope
- Recent history of steroid or non-steroidal anti-inflammatory drug use
- Systemic illness with presenting complaints of sore/dry throat (diabetics with polydipsia, hypertensives on diuretics, moribund bed ridden patients)
- History of airway related morbidity post operative sore throat [POST]
- Patients with a history of chronic smoking (1 pack per day for 10 years) chewing tobacco, and tobacco-related products
Show all 12Show fewer
- Patients undergoing head and neck, intraoral/nasal surgery, or recent history of such surgery
- Patients with a past surgical history of tracheostomy (post decannulation)
- Surgery in prone position
- Ongoing upper and lower respiratory tract inflammation/infection
- Patients with anticipated postoperative mechanical ventilation
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
India1 site
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
About this study
Official title: Effect of Kinetic Contact-friction Modulation With a Pre-inflated Tracheal Tube Cuff on Postoperative Sore Throat in Adults With Anticipated Non-difficult Airway: a Randomized Controlled Study
Postoperative sore throat (POST) is a common morbidity following upper airway access-control with direct laryngoscopy-intubation (DLI) technique. Various reasons (size of the tracheal tube, cuff pressure, rough tube pass, and reattempts, among others) have been cited and management strategies (pharmacologic: applying lidocaine gel/EMLA cream on the cuff surface; non-pharmacologic measures: tracheal tube cuff pressure control, optimization of tracheal tube size, applying lubricating gel) have been tried, but none has been able to decrease the incidence of POST nor has been able to decrease the suffering of patients.
Traditionally, intubation is performed with a deflated endotracheal tube and the cuff is later inflated to secure the tube in desired position. The striated folds present in the deflated cuff incurs additional dynamic friction that traumatizes upper airway mucosa during the procedure, causing the risk of POST. While accentuated friction burden on the posterior part of vocal cords and the tracheal mucosa has been studied recently, there has been no work on understanding the kinetic contact- friction ensued by a passing tracheal tube/cuff. We speculate that dynamic contact-friction generated at the time of passing of a cuffed tracheal tube is the major active component which has potential to cause actual tissue trauma and inflammation resulting in adverse effects (POST, hoarseness, throat pain, cough). This study aims to evaluate the effects of reducing dynamic/kinetic contact-friction by employing a pre-inflated tracheal tube cuff to pass the vocal cords at the time of orotracheal intubation.
Read the detailed description
Postoperative sore throat (POST) has long been a common and nagging complication following conventional direct laryngoscopy-intubation (DLI) procedure. A significant quantum of POST incidence during DLI in non-difficult airway (NDA) could be attributed to inter-operator variability in approach, experience, proficiency, and equipment (e.g., type of laryngoscope/tracheal tube). Additional factors determining the occurrence of POST, include size of the tracheal tube, cuff pressure, rough tube pass, and reattempts, among others. Several pharmacologic (applying lidocaine gel, inhaled corticosteroids and EMLA cream on tracheal tube cuff surface) and non- pharmacologic measures/modalities (e.g., tracheal tube cuff pressure control, optimization of tracheal tube size, applying gel) have been employed to preclude/diminish POST, however, neither the incidence nor the suffering of patients have come down yet following these interventions. Friction injury to the tracheal mucosa during the passage of ETT is one of the important contributing factors to POST but has not been adequately evaluated. Friction injury to the upper airway mucosa not only occurs during rough or repeated passage of ETT through the glottic-inlet but also when the ETT cuff comes in contact with the tracheal mucosa during dynamic passage of ETT through the glottis.
Traditional approach to reduce reduce postoperative sore throat is by containing the intracuff pressure with use of non-inflated tube, and consequently, reducing static pressure burden on tracheal mucosa. No study has explored the impact of modulation of obligate kinetic contact-friction that occurs during passage of tube across the glottic-inlet. A preemptive limited inflation of tracheal tube cuff before actual intubation may modulate the kinetic-contact friction during the passage of the tracheal tube cuff past the vocal cords, and hence may help reduce postoperative sore throat in these patients. We plan this randomized trial to compare the effect/efficacy of intubation with pre-inflated tracheal tube on the incidence of postoperative sore throat in patients with anticipated non-difficult airway.
- Conditions
- Postoperative Sore Throat
- Being tested
- Pre-inflated endotracheal tube, Non-inflated endotracheal tube
- Keywords
- endotracheal tube, inflated, sore throat, friction
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-inflated endotracheal tubeOther
The ETT (males: size 7.5 mm ID, females: size 6.5 mmID) will be taken out from the wrapper and submerged in 0.9% normal saline till the proximal margin of the cuff. Then, the cuff will be inflated to 40 cm of H2O to gain full stretch inflation.Thereafter the cuff will be deflated with the help of cuff inflator-deflator device to maintain intracuff pressure of 4 cm H2O The external cuff balloon will be obliterated with a soft clamp to ensure that at the time of passage of tube through the glottic-inlet, the tube cuff does not get deflated due to pressure equalization with the external balloon.
Non-inflated endotracheal tubeOther
The ETT (males: size 7.5 mm ID, females: size 6.5 mmID) will be taken out from the wrapper and submerged in 0.9% normal saline till the proximal margin of the cuff. Thereafter the endotracheal intubation will be done.
| Study group | Role | What they receive |
|---|---|---|
| Intubation with pre-inflated ETT | Active comparator | Patient's trachea will be intubated using pre- inflated endotracheal tube (ETT) Receives: Other: Pre-inflated endotracheal tube |
| Intubation with non-inflated ETT | Active comparator | Patient's trachea will be intubated using non-inflated ETT Receives: Other: Non-inflated endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative sore throat
Sore throat will be assessed using a 4-point scale: '0' no sore throat to '3' severe sore throat.Any score >= 1 will be counted as a sore throat incidence
Measured: From time of extubation of trachea till 24-hours postoperatively
Secondary outcomes (3)
Severity of postoperative sore throat
Sore throat will be assessed using a 4-point scale: '0' no sore throat, '1' Mild sore throat (complained of sore throat only on enquiry), '2' Moderate sore throat (complained of sore throat on his/her own), and '3' Severe sore throat (change of voice or hoarseness). Number of patients with no sore throat, mild sore throat, moderate sore throat, and severe sore throat will be noted
Measured: From time of extubation of trachea till 24-hours postoperatively
Incidence and severity of postoperative cough
Postoperative cough will be assessed using a 4-point scale: 0- no cough, 1- mild cough (cough which is less than a common cold), 2-moderate cough (cough which is similar to a common cold), and 3- severe cough (cough which is more than a common cold).
Measured: From time of extubation of trachea till 24-hours postoperatively
Incidence and severity of postoperative hoarseness of voice
Postoperative hoarseness of voice will be assessed using a 4-point scale: 0- no hoarseness (no change in speech appreciated even on enquiry), 1- mild hoarseness (minimal change in speech quality. Answered by patient on enquiry), 2-moderate hoarseness (moderate change in speech quality which is self-complained by the patient), and 3- severe hoarseness (recognizable change in speech quality).
Measured: From time of extubation of trachea till 24-hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start23 Jan 2024
- Primary completion21 Jul 2025
- Study completion21 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sore ThroatStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly divided into two groups: Group I: Intubation with pre-inflated endotracheal tube Group II: Intubation with non-inflated endotracheal tube
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Ganga Ram Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nitin Sethi, DNB, Sir Ganga Ram Hospital
- Investigators
- Amitabh Dutta, MD, PGDHR, Study director, Sir Ganga Ram Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218836
- Sponsor's protocol ID
- EC/12/23/2408
- Status last verified
- Apr 2026
- First submitted
- 12 Jan 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinetic Contact-friction Modulation With a Pre-inflated Tracheal Tube Cuff on Postoperative Sore Throat in Adults With Anticipated Non-difficult Airway: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06218836
- Acronym / sponsor ID
- EC/12/23/2408
- Conditions
- Postoperative Sore Throat
- Keywords
- endotracheal tube, inflated, sore throat, friction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Sir Ganga Ram HospitalUniversity, hospital or other
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 21 Jul 2025 (actual)
- First posted
- 23 Jan 2024 (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.
Postoperative sore throat (POST) is a common morbidity following upper airway access-control with direct laryngoscopy-intubation (DLI) technique. Various reasons (size of the tracheal tube, cuff pressure, rough tube pass, and reattempts, among others) have been cited and management strategies (pharmacologic: applying lidocaine gel/EMLA cream on the cuff surface; non-pharmacologic measures: tracheal tube cuff pressure control, optimization of tracheal tube size, applying lubricating gel) have been tried, but none has been able to decrease the incidence of POST nor has been able to decrease the suffering of patients.
Traditionally, intubation is performed with a deflated endotracheal tube and the cuff is later inflated to secure the tube in desired position. The striated folds present in the deflated cuff incurs additional dynamic friction that traumatizes upper airway mucosa during the procedure, causing the risk of POST. While accentuated friction burden on the posterior part of vocal cords and the tracheal mucosa has been studied recently, there has been no work on understanding the kinetic contact- friction ensued by a passing tracheal tube/cuff. We speculate that dynamic contact-friction generated at the time of passing of a cuffed tracheal tube is the major active component which has potential to cause actual tissue trauma and inflammation resulting in adverse effects (POST, hoarseness, throat pain, cough). This study aims to evaluate the effects of reducing dynamic/kinetic contact-friction by employing a pre-inflated tracheal tube cuff to pass the vocal cords at the time of orotracheal intubation.
Detailed description
Postoperative sore throat (POST) has long been a common and nagging complication following conventional direct laryngoscopy-intubation (DLI) procedure. A significant quantum of POST incidence during DLI in non-difficult airway (NDA) could be attributed to inter-operator variability in approach, experience, proficiency, and equipment (e.g., type of laryngoscope/tracheal tube). Additional factors determining the occurrence of POST, include size of the tracheal tube, cuff pressure, rough tube pass, and reattempts, among others. Several pharmacologic (applying lidocaine gel, inhaled corticosteroids and EMLA cream on tracheal tube cuff surface) and non- pharmacologic measures/modalities (e.g., tracheal tube cuff pressure control, optimization of tracheal tube size, applying gel) have been employed to preclude/diminish POST, however, neither the incidence nor the suffering of patients have come down yet following these interventions. Friction injury to the tracheal mucosa during the passage of ETT is one of the important contributing factors to POST but has not been adequately evaluated. Friction injury to the upper airway mucosa not only occurs during rough or repeated passage of ETT through the glottic-inlet but also when the ETT cuff comes in contact with the tracheal mucosa during dynamic passage of ETT through the glottis.
Traditional approach to reduce reduce postoperative sore throat is by containing the intracuff pressure with use of non-inflated tube, and consequently, reducing static pressure burden on tracheal mucosa. No study has explored the impact of modulation of obligate kinetic contact-friction that occurs during passage of tube across the glottic-inlet. A preemptive limited inflation of tracheal tube cuff before actual intubation may modulate the kinetic-contact friction during the passage of the tracheal tube cuff past the vocal cords, and hence may help reduce postoperative sore throat in these patients. We plan this randomized trial to compare the effect/efficacy of intubation with pre-inflated tracheal tube on the incidence of postoperative sore throat in patients with anticipated non-difficult airway.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly divided into two groups: Group I: Intubation with pre-inflated endotracheal tube Group II: Intubation with non-inflated endotracheal tube
| Arm | Type | Receives |
|---|---|---|
| Intubation with pre-inflated ETT | Active comparator | Other: Pre-inflated endotracheal tubePatient's trachea will be intubated using pre- inflated endotracheal tube (ETT) |
| Intubation with non-inflated ETT | Active comparator | Other: Non-inflated endotracheal tubePatient's trachea will be intubated using non-inflated ETT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA physical status I and II
- Patients with anticipated non-difficult airway with the following characteristics:
- Surgeries with anticipated duration of 40 minutes - 3 hours
Key exclusion criteria (12 listed)
- Obese patients (BMI > 33 kg/m2)
- Requiring use of intubation aids such as bougie, stylet or video-laryngoscope
- Recent history of steroid or non-steroidal anti-inflammatory drug use
- Systemic illness with presenting complaints of sore/dry throat (diabetics with polydipsia, hypertensives on diuretics, moribund bed ridden patients)
- History of airway related morbidity post operative sore throat [POST]
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 |
|---|---|---|
| Pre-inflated endotracheal tubeThe ETT (males: size 7.5 mm ID, females: size 6.5 mmID) will be taken out from the wrapper and submerged in 0.9% normal saline till the proximal margin of the cuff. Then, the cuff will be inflated to 40 cm of H2O to gain full stretch inflation.Thereafter the cuff will be deflated with the help of cuff inflator-deflator device to maintain intracuff pressure of 4 cm H2O The external cuff balloon will be obliterated with a soft clamp to ensure that at the time of passage of tube through the glottic-inlet, the tube cuff does not get deflated due to pressure equalization with the external balloon. | Other | Intubation with pre-inflated ETT |
| Non-inflated endotracheal tubeThe ETT (males: size 7.5 mm ID, females: size 6.5 mmID) will be taken out from the wrapper and submerged in 0.9% normal saline till the proximal margin of the cuff. Thereafter the endotracheal intubation will be done. | Other | Intubation with non-inflated ETT |
Primary outcome
Incidence of postoperative sore throat
Time frame: From time of extubation of trachea till 24-hours postoperatively
Sore throat will be assessed using a 4-point scale: '0' no sore throat to '3' severe sore throat.Any score >= 1 will be counted as a sore throat incidence
3 secondary outcomes
Severity of postoperative sore throat
Time frame: From time of extubation of trachea till 24-hours postoperatively
Incidence and severity of postoperative cough
Time frame: From time of extubation of trachea till 24-hours postoperatively
Incidence and severity of postoperative hoarseness of voice
Time frame: From time of extubation of trachea till 24-hours postoperatively
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 27 Apr 2026.
- 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.
Amitabh Dutta, MD, PGDHR study director
Sir Ganga Ram Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-inflated endotracheal tube and Non-inflated endotracheal tube in people with Postoperative Sore Throat, run by Sir Ganga Ram Hospital 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 4 inclusion and 12 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 27 Apr 2026. 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?
Incidence of postoperative sore throat (time frame: From time of extubation of trachea till 24-hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.