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

NCT04708964 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-01-14

No results posted yet for this 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.

Conditions

  • D010612

Interventions

DRUG

Flurbiprofen

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

DRUG

saline solution

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

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Maria Calabrese, MD · Fondazione Policlinico A. Gemelli IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2021-06-30
Completion
2022-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04708964 on ClinicalTrials.gov