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.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Phase 2, Interventional, and Treatment
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.
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.
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 →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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The New York Heart Association’s four classes of how much heart failure limits physical activity.
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NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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Excipients
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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
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
Flurbiprofen solution will be administered, through the subglottic intake door of the endotracheal tube.
Saline solution will be administered, through the subglottic intake door of the endotracheal tube.
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
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
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
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Plan to share: No
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Start is estimated for Jan 2021; primary completion for Jun 2021, 5 months later.
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Studies of the drug tested here: Flurbiprofen
Fondazione Policlinico Universitario Agostino Gemelli IRCCS →