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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:
Exclusion criteria:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Usual respiratory care | |
| Supranav | Active Comparator | Respiratory care with "supranav" which is a continuous supraglottic suction device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supranav | Device | Continuous supraglottic suction device for patients with orotraqueal intubation an mechanical ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator associated events | 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. | 24 hours after extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of patientes with Bleeding and lacerations in the oropharynx | 24 hours after extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alba L Ramirez Sarmiento, PhD | Fundación Cardiovascular de Colombia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación Cardiovascular de Colombia | Piedecuesta | Santander Department | 681011 | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40161252 | Derived | Orozco-Levi M, Tiga-Loza DC, Aya O, Reyes CF, Caceres-Rivera D, Espitia A, Rey D, Pedrozo Arias KP, Pizarro C, Sanabria-Barrera SM, Serrano-Diaz N, Castillo VR, Ramirez-Sarmiento A. A Novel Supraglottic Suction Device in Mechanically Ventilated Patients: A Randomized Controlled Trial. Med Devices (Auckl). 2025 Mar 24;18:201-212. doi: 10.2147/MDER.S499924. eCollection 2025. |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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