D010612Phase 2SoreThroatNCT04708964
Oro-tracheal Intubation: Flurbiprofen Subglottic Instillation to Prevent Laryngeal Inflammation
A Phase 2 study testing Flurbiprofen and saline solution in people with D010612, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Most efficient system for airways controll during general anesthesia is oro-tracheal intubation, in order to allow mechanical ventilation and bronchial suction and to prevent gastric intake. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- D010612
- What is being tested?
- Flurbiprofen and saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to 31 Jan 2022
- Phase
- Phase 2
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Orotracheal intubation lasting 9-12 hours for elective interventions of myocardial revascularization or replacement/valve plastic in extracorporeal circulation and subsequent stay in intensive care.
- Ages of 50 and 75
- CLASS NYHA I or II
- Written consent to participation in the study and processing of their clinical data for the purpose of the study
Who cannot join
- Previous upper air screw surgery
- Positive history for recent acute or chronic diseases of upper airways
- Tabagism
- Positive history for difficult intubation
- Orotracheal intubation with more than two attempts or with the help of devices
- Naso-tracheal intubation
Show all 13Show fewer
- Positive history for gastro-esophageal reflux
- Patients who have or have been affected by peptic ulcer
- Patients with known hypersensitivity (bronchial asthma, urticaria, allergic phenomena) to flurbiprofen or any of the excipients, and to aspirin and other drugs belonging to the category of nonsteroidal anti-inflammatory drugs (NSAIDs)
- Pregnant and lactating women
- Patients participating in other experimental trials
- Patients who have not given written consent
- Any other clinical condition that the investigator says would make the patient unfit for study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Subglottic Instillation of Flurbiprofen to Prevent Laryngeal Inflammation Resulting From Endotracheal Intubation: Prospective Pilot Study, Randomized, Double Blind, Placebo Controlled.
Most efficient system for airways controll during general anesthesia is oro-tracheal intubation, in order to allow mechanical ventilation and bronchial suction and to prevent gastric intake. However, in the period after exhumation, traumatism of tube placement causes in 21% to 72% of patients, sore throat (POST), generally associated hoarseness. The incidence of POST is influenced by numerous factors such as age, smoke history, duration of tube positioning maneuvers, diameter of the endotracheal tube, pressure present in the headset, duration of intubation. Although analgesics and systemically administered anti-inflammatories have been found to be effective, topical therapies based on the application of corticosteroids, NSAIDs and lidocaine are an interesting alternative because they are also effective, but devoid of the effects collateralises of systemic administration. The proposed methods for the prevention and treatment of POST in cardiac surgery patients, subjected to long-term interventions with consequent need for prolonged mechanical ventilation and therefore orotracheal intubation even in the post-operative period. The propose of trial is that the sub-glottal intake door can also be used for the peat administration of anti-inflammatory drugs in order to prevent pain caused by endotracheal intubation. This drug thus administered will directly reach the anatomical structures most involved in the genesis of post-intubation pain, that is, the vocal cords and the expected part of the trachea.
Read the detailed description
Orotracheal intubation is the most efficient system for controlling the airways during general anesthesia, in order to keep them harmful, to prevent gastric intake and to allow mechanical ventilation and bronchial suction. However, a percentage ranging from 21% to 72% of patients undergoing orotracheal intubation have, in the period after exhumation, sore throat (POST) generally associated hoarseness. This complication stems from traumatism caused by tube placement and pressure exerted on the vocal cords and trachea wall during in situ parking. The incidence of POST is influenced by numerous factors such as age, smoke history, duration of tube positioning maneuvers, diameter of the endotracheal tube, pressure present in the headset, duration of intubation. The proposed methods for the prevention and treatment of POST are manifold and the literature on the subject is extensive. Several studies have assessed the effectiveness of systemic administration of opioids and NSAIDs or their peat application, by oral rinse and gargles, and the lubrication of the endotracheal tube cap with cortisonic or lidocaine-based ointments. Although analgesics and systemically administered anti-inflammatories have been found to be effective, topical therapies based on the application of corticosteroids, NSAIDs and lidocaine are an interesting alternative because they are also effective, but devoid of the effects collateralises of systemic administration. Among the drugs used in this mode there is also flurbiprofen, an NSAID successfully used in inflammation of the first airways which has also proven effective in the forms resulting from endotracheal intubation and the placement of the laryngeal mask. There are studies in the literature that have evaluated the oral administration of flurbiprofen spray. Recently, endotracheal tubes have been marketed to remove secretions that accumulate above the headset, sucking them through an accessory light. These secretions come from the upper airways and penetrate the initial part of the trachea because the presence of the endotracheal tube prevents the adduction of the vocal cords. The permanence of secretions facilitates bacterial growth and, in the long run, their passage under the cap, into the tracheobronchial tree. For this reason, the use of these tubes has been effective in reducing the incidence of pneumonia associated with invasive mechanical ventilation. The accessory light (sub-glottal suction door) has also been used to carry out washing with physiological solution, always in order to prevent material stagnation and bacterial growth above the headset. The propose of trial is that the sub-glottal intake door can also be used for the peat administration of anti-inflammatory drugs in order to prevent pain caused by endotracheal intubation. In fact, a drug thus administered will directly reach the anatomical structures most involved in the genesis of post-intubation pain, that is, the vocal cords and the expected part of the trachea. The population studied will be cardiac surgery, subjected to long-term interventions with consequent need for prolonged mechanical ventilation and therefore orotracheal intubation even in the post-operative period.
- Conditions
- D010612
- Being tested
- Flurbiprofen, saline solution
- Keywords
- Sore Throat, Endotracheal Intubation, Flurbiprofen
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlurbiprofenDrug
Flurbiprofen solution will be administered, through the subglottic intake door of the endotracheal tube.
saline solutionDrug
Saline solution will be administered, through the subglottic intake door of the endotracheal tube.
| Study group | Role | What they receive |
|---|---|---|
| Flurbiprofen | Active comparator | 5 ml of flurbiprofen solution 0.25% will be administered, through the subglottic intake door of the endotracheal tube. The solution will be left in place for 1 minute Receives: Drug: Flurbiprofen |
| Placebo | Placebo comparator | 5 ml of saline solution 0.9% will be administered, through the subglottic intake door of the endotracheal tube. The solution will be left in place for 1 minute Receives: Drug: saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of a flurbiprofen solution, administered through the subglottic intake port of endotracheal tubes, on the incidence and intensity of the Sore Throat Post Operative
Decrease of Sore Throat Pain Intensity Scale (STPIS) and Throat Pain Scale (TPS)
Measured: ● T3: three hours after endotracheal tube removal ● T12: twelve hours after endotracheal tube removal (1 postoperative day) ● T 36: 36 hours after endotracheal tube removal (2 postoperative day) ●TDim: Time of discharge
Secondary outcomes (2)
Evaluate the intensity of hoarseness Evaluate the intensity of hoarseness
Categorical scale (0 = absence of hoarseness, 1= hoarseness sensation, 2= hoarseness clearly perceived by others, 3= marked hoarseness
Measured: ● T3: three hours after endotracheal tube removal ● T12: twelve hours after endotracheal tube removal (1 postoperative day) ● T 36: 36 hours after endotracheal tube removal (2 postoperative day) ● TDim: Time of discharge
Patients Satisfaction
SATIS scale: 0 = extremely dissatisfied, 1 = very dissatisfied 2= dissatisfied 3 = a little satisfied, 4 = satisfied, 5 = very satisfied, 6 = extremely satisfied)
Measured: ● T3: three hours after endotracheal tube removal ● T12: twelve hours after endotracheal tube removal (1 postoperative day) ● T 36: 36 hours after endotracheal tube removal (2 postoperative day) ● TDim: Time of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study startJan 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for D010612Studies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.ssa M Calabrese, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Maria Calabrese, MD, Principal investigator, Fondazione Policlinico A. Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708964
- Sponsor's protocol ID
- Sore Throat Pilot
- Acronym
- SoreThroat
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 14 Jan 2021
- 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 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subglottic Instillation of Flurbiprofen to Prevent Laryngeal Inflammation Resulting From Endotracheal Intubation: Prospective Pilot Study, Randomized, Double Blind, Placebo Controlled.
- ClinicalTrials.gov ID
- NCT04708964
- Acronym / sponsor ID
- SoreThroat / Sore Throat Pilot
- Conditions
- D010612
- Keywords
- Sore Throat, Endotracheal Intubation, Flurbiprofen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 14 Jan 2021 (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.
Most efficient system for airways controll during general anesthesia is oro-tracheal intubation, in order to allow mechanical ventilation and bronchial suction and to prevent gastric intake. However, in the period after exhumation, traumatism of tube placement causes in 21% to 72% of patients, sore throat (POST), generally associated hoarseness. The incidence of POST is influenced by numerous factors such as age, smoke history, duration of tube positioning maneuvers, diameter of the endotracheal tube, pressure present in the headset, duration of intubation. Although analgesics and systemically administered anti-inflammatories have been found to be effective, topical therapies based on the application of corticosteroids, NSAIDs and lidocaine are an interesting alternative because they are also effective, but devoid of the effects collateralises of systemic administration. The proposed methods for the prevention and treatment of POST in cardiac surgery patients, subjected to long-term interventions with consequent need for prolonged mechanical ventilation and therefore orotracheal intubation even in the post-operative period. The propose of trial is that the sub-glottal intake door can also be used for the peat administration of anti-inflammatory drugs in order to prevent pain caused by endotracheal intubation. This drug thus administered will directly reach the anatomical structures most involved in the genesis of post-intubation pain, that is, the vocal cords and the expected part of the trachea.
Detailed description
Orotracheal intubation is the most efficient system for controlling the airways during general anesthesia, in order to keep them harmful, to prevent gastric intake and to allow mechanical ventilation and bronchial suction. However, a percentage ranging from 21% to 72% of patients undergoing orotracheal intubation have, in the period after exhumation, sore throat (POST) generally associated hoarseness. This complication stems from traumatism caused by tube placement and pressure exerted on the vocal cords and trachea wall during in situ parking. The incidence of POST is influenced by numerous factors such as age, smoke history, duration of tube positioning maneuvers, diameter of the endotracheal tube, pressure present in the headset, duration of intubation. The proposed methods for the prevention and treatment of POST are manifold and the literature on the subject is extensive. Several studies have assessed the effectiveness of systemic administration of opioids and NSAIDs or their peat application, by oral rinse and gargles, and the lubrication of the endotracheal tube cap with cortisonic or lidocaine-based ointments. Although analgesics and systemically administered anti-inflammatories have been found to be effective, topical therapies based on the application of corticosteroids, NSAIDs and lidocaine are an interesting alternative because they are also effective, but devoid of the effects collateralises of systemic administration. Among the drugs used in this mode there is also flurbiprofen, an NSAID successfully used in inflammation of the first airways which has also proven effective in the forms resulting from endotracheal intubation and the placement of the laryngeal mask. There are studies in the literature that have evaluated the oral administration of flurbiprofen spray. Recently, endotracheal tubes have been marketed to remove secretions that accumulate above the headset, sucking them through an accessory light. These secretions come from the upper airways and penetrate the initial part of the trachea because the presence of the endotracheal tube prevents the adduction of the vocal cords. The permanence of secretions facilitates bacterial growth and, in the long run, their passage under the cap, into the tracheobronchial tree. For this reason, the use of these tubes has been effective in reducing the incidence of pneumonia associated with invasive mechanical ventilation. The accessory light (sub-glottal suction door) has also been used to carry out washing with physiological solution, always in order to prevent material stagnation and bacterial growth above the headset. The propose of trial is that the sub-glottal intake door can also be used for the peat administration of anti-inflammatory drugs in order to prevent pain caused by endotracheal intubation. In fact, a drug thus administered will directly reach the anatomical structures most involved in the genesis of post-intubation pain, that is, the vocal cords and the expected part of the trachea. The population studied will be cardiac surgery, subjected to long-term interventions with consequent need for prolonged mechanical ventilation and therefore orotracheal intubation even in the post-operative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flurbiprofen | Active comparator | Drug: Flurbiprofen5 ml of flurbiprofen solution 0.25% will be administered, through the subglottic intake door of the endotracheal tube. The solution will be left in place for 1 minute |
| Placebo | Placebo comparator | Drug: saline solution5 ml of saline solution 0.9% will be administered, through the subglottic intake door of the endotracheal tube. The solution will be left in place for 1 minute |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Orotracheal intubation lasting 9-12 hours for elective interventions of myocardial revascularization or replacement/valve plastic in extracorporeal circulation and subsequent stay in intensive care.
- Ages of 50 and 75
- CLASS NYHA I or II
- Written consent to participation in the study and processing of their clinical data for the purpose of the study
Key exclusion criteria (13 listed)
- Previous upper air screw surgery
- Positive history for recent acute or chronic diseases of upper airways
- Tabagism
- Positive history for difficult intubation
- Orotracheal intubation with more than two attempts or with the help of devices
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 |
|---|---|---|
| FlurbiprofenFlurbiprofen solution will be administered, through the subglottic intake door of the endotracheal tube. | Drug | Flurbiprofen |
| saline solutionSaline solution will be administered, through the subglottic intake door of the endotracheal tube. | Drug | Placebo |
Primary outcome
Evaluate the effectiveness of a flurbiprofen solution, administered through the subglottic intake port of endotracheal tubes, on the incidence and intensity of the Sore Throat Post Operative
Time frame: ● T3: three hours after endotracheal tube removal ● T12: twelve hours after endotracheal tube removal (1 postoperative day) ● T 36: 36 hours after endotracheal tube removal (2 postoperative day) ●TDim: Time of discharge
Decrease of Sore Throat Pain Intensity Scale (STPIS) and Throat Pain Scale (TPS)
2 secondary outcomes
Evaluate the intensity of hoarseness Evaluate the intensity of hoarseness
Time frame: ● T3: three hours after endotracheal tube removal ● T12: twelve hours after endotracheal tube removal (1 postoperative day) ● T 36: 36 hours after endotracheal tube removal (2 postoperative day) ● TDim: Time of discharge
Patients Satisfaction
Time frame: ● T3: three hours after endotracheal tube removal ● T12: twelve hours after endotracheal tube removal (1 postoperative day) ● T 36: 36 hours after endotracheal tube removal (2 postoperative day) ● TDim: Time of discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: No
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.
Maria Calabrese, MD principal investigator
Fondazione Policlinico A. Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flurbiprofen and saline solution in people with D010612, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 13 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: status not confirmed, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Calabrese, MD (+393925532600, maria.calabrese@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effectiveness of a flurbiprofen solution, administered through the subglottic intake port of endotracheal tubes, on the incidence and intensity of the Sore Throat Post Operative (time frame: ● T3: three hours after endotracheal tube removal ● T12: twelve hours after endotracheal tube removal (1 postoperative day) ● T 36: 36 hours after endotracheal tube removal (2 postoperative day) ●TDim: Time of discharge). 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 14 Jan 2021.