ClinicalTrials.gg
Status unknownNCT04708964SoreThroatUpdated Jan 14, 2021

Oro-tracheal Intubation: Flurbiprofen Subglottic Instillation to Prevent Laryngeal Inflammation

A Phase 2 interventional study of Flurbiprofen and saline solution in D010612, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Status unknown. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-01-14.

Primary conditionPharyngitis(the registry's first term)UnverifiedIs this wrong?The registry often attaches Pharyngitis to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • D010612

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Keywords

  • Sore Throat
  • Endotracheal Intubation
  • Flurbiprofen
03

In context

Pharyngitis Unverified

226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.

This study's planned enrollment of 70 is below the median of 144 across 188 interventional studies indexed under Pharyngitis.

Browse Pharyngitis studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.

Compared within Pharyngitis, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 I or II
  • Written consent to participation in the study and processing of their clinical data for the purpose of the study

Exclusion criteria

Exclusion Criteria:

  • 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
  • Positive history for gastro-esophageal reflux
  • Patients who have or have been affected by peptic ulcer
  • Patients with known (bronchial asthma, urticaria, allergic phenomena) to flurbiprofen or any of the , 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    Flurbiprofen

    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

    Drug: Flurbiprofen

  • Placebo comparator
    Placebo

    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

    Drug: saline solution

Interventions

  • Flurbiprofen solution will be administered, through the subglottic intake door of the endotracheal tube.

  • Drugsaline solution

    Saline solution will be administered, through the subglottic intake door of the endotracheal tube.

06

What researchers measure

Primary outcomes

  1. 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)

    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

Secondary outcomes

  1. 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

    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

  2. Patients Satisfaction

    SATIS scale: 0 = extremely dissatisfied, 1 = very dissatisfied 2= dissatisfied 3 = a little satisfied, 4 = satisfied, 5 = very satisfied, 6 = extremely satisfied)

    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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2021; primary completion for Jun 2021, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 11, 2021
First posted
Jan 14, 2021
StartEst.
Jan 2021
Primary completionEst.
Jun 30, 2021
CompletionEst.
Jan 31, 2022
Last update
Jan 14, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04708964
Responsible party
Dr.ssa M Calabrese (MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Jan 14, 2021
Start date
Jan 2021 (estimated)
Primary completion
Jun 30, 2021 (estimated)
Completion
Jan 31, 2022 (estimated)
Last update
Jan 14, 2021

Study contacts

Maria Calabrese, MD
Contact
maria.calabrese@policlinicogemelli.it
+393925532600
Temistocle Taccheri, MD
Contact
taccheri.temistocle@gmail.com
+393470526726
Maria Calabrese, MD
principal investigator · Fondazione Policlinico A. Gemelli IRCCS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Flurbiprofen

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