Fundación Cardiovascular de Colombia
Piedecuesta, Santander Department, 681011, Colombia
NCT Number: NCT03573609
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Piedecuesta, Santander Department, 681011, Colombia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous supraglottic suction device for patients with orotraqueal intubation an mechanical ventilation
Time frame: 24 hours after extubation
A group of all the conditions that result in a significant and sustained deterioration in oxygenation, defined as a greater than 20% increase in the daily minimum fraction of inspired oxygen or an increase of at least 3 cm H2O in the daily minimum positive end-expiratory pressure (PEEP) to maintain oxygenation. It is imperative to understand that both infectious conditions (such as tracheitis, tracheobronchitis, and pneumonia) and noninfectious conditions (such as atelectasis, pulmonary embolism, pulmonary edema, ventilator-induced lung injury, and others) may fulfill this VAE definition.
Time frame: 24 hours after extubation
Number of patientes with Bleeding and lacerations in the oropharynx
Fundación Cardiovascular de Colombia
Other
Multicenter, Controlled, Randomized Clinical Trial to Evaluate the Effectiveness and Safety of the New Supratube Invention Device to Prevent Pneumonia Associated With Mechanical Ventilation: " Supra-nav Project "
Acronym: SUPRANAV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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