Intensive Critical Unit clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT03573609 Completed - Pneumonia Clinical Trials

Evaluation of the Effectiveness and Safety of Supratube Device

SUPRANAV

Start date: May 29, 2018
Phase: N/A
Study type: Interventional

Purpose of the trial: Trial design: Two-parallel arm, double-blind, individually randomized controlled trial. Primary endpoint: Clinical evaluation of sinus, oropharyngeal, tracheal, bronchial or pulmonary infections during orotracheal intubation and hospital admission. Secondary endpoints: Volume of oropharyngeal secretions aspirated per unit of time (for 24 hours) by the SupraTube and Complications during the use of the SupraTube device: erosions, lacerations, Bleeding, displacement, migration, need for withdrawal. Inclusion criteria: - Adult patient - Orotracheal intubation ≤ 72 hours - Hospitalized in ICU - integrity of upper airways Exclusion criteria: - International patients - Coagulopathic patients - oncology patients - patients with maxillofacial surgery - Absence of close responsible family member - Tracheostomy, shock, local or systemic non-controlled infection Trial treatment: Intervention: Aspiration of secretions with the supranav device Control: Usual respiratory care Expected sample size, enrollment and expected number of centers: Sample size = 108 Recruitment start date: Recruitment end date: Follow-up end date: Number of centers: 2 Statistical considerations: - Intention to treat analysis - The primary outcomes will be analyzed using