Oro-tracheal Intubation: Flurbiprofen Subglottic Instillation to Prevent Laryngeal Inflammation (SoreThroat)
Subglottic Instillation of Flurbiprofen to Prevent Laryngeal Inflammation Resulting From Endotracheal Intubation: Prospective Pilot Study, Randomized, Double Blind, Placebo Controlled.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
Study Contact
- Name: Maria Calabrese, MD
- Phone Number: +393925532600
- Email: maria.calabrese@policlinicogemelli.it
Study Contact Backup
- Name: Temistocle Taccheri, MD
- Phone Number: +393470526726
- Email: taccheri.temistocle@gmail.com
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 NYHA I or II
- Written consent to participation in the study and processing of their clinical data for the purpose of the study
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 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
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
|
Flurbiprofen solution will be administered, through the subglottic intake door of the endotracheal tube.
|
|
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
|
Saline solution will be administered, through the subglottic intake door of the endotracheal tube.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
● 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 Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Categorical scale (0 = absence of hoarseness, 1= hoarseness sensation, 2= hoarseness clearly perceived by others, 3= marked hoarseness
|
● 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
|
SATIS scale: 0 = extremely dissatisfied, 1 = very dissatisfied 2= dissatisfied 3 = a little satisfied, 4 = satisfied, 5 = very satisfied, 6 = extremely satisfied)
|
● 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
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Maria Calabrese, MD, Fondazione Policlinico A. Gemelli IRCCS
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Study Start
Primary Completion (ANTICIPATED)
Primary Completion
Study Completion (ANTICIPATED)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Otorhinolaryngologic Diseases
- Laryngeal Diseases
- Inflammation
- Laryngitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Flurbiprofen
Other Study ID Numbers
Other Study ID Numbers
- Sore Throat Pilot
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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