Trial reportMedical devices (Auckland, N.Z.)2025
A Novel Supraglottic Suction Device in Mechanically Ventilated Patients: A Randomized Controlled Trial.
Trial report in Medical devices (Auckland, N.Z.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03573609 (Multicenter, Controlled, Randomized Clinical Trial to Evaluate the Effectiveness and Safety of the New Supratube Invention Device to Prevent Pneumonia Associated With Mechanical Ventilation), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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 "
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objective: To evaluate the efficacy and safety of the SUPRAtube innovation device in preventing ventilator associated events and fluid accumulation in the supraglottic region in patients receiving mechanical ventilation (MV) through orotracheal tubes. Methods: Multicenter, controlled, randomized, parallel, open-label clinical trial with a 1:1 allocation ratio of MV patients compared the use of the SUPRAtube elastomeric device with standard care and aspiration techniques. A series of computer-random numbers and centralized allocation with sealed envelopes were used. Setting: Adult patients (n=108; mean age: 63 yrs, range: 19-85) hospitalized in intensive care units of two centers, the Cardiovascular Foundation of Colombia and the International Hospital of Colombia (Santander, Colombia), were included. All patients received MV through orotracheal tubes, were hemodynamically stable, had upper airway integrity according to fiberoptic bronchoscope findings, and had basic coagulation tests within acceptable risk criteria. Interventions: Comprehensive standard of care, including preventive strategies, medical therapy, positive pressure MV, and routine procedures for management of oropharyngeal and pulmonary secretions (humidification, patient mobilization, and airway suctioning), was compared with the standard of care plus continuous supraglottic suction with the new SUPRAtube device. Results: The study period reached five days before extubation (media 85±7 hours). The weight of the aspirated content was 415 g (P25;P75: 396;536) in the control group and 624 g (P25;P75: 469;824) in the SUPRAtube group (p<0.001), equivalent to a mean difference of 213 g (P Conclusion: Continuous supraglottic aspiration using SUPRAtube is complementary, effective, safe, simple, and inexpensive and reduces the accumulation of oropharyngeal secretions in mechanically ventilated patients. The relevant clinical benefit in terms of preventing and improving tracheobronchitis earlier on was demonstrated by sequential fiberoptic bronchoscopy. Registration in Clinical Trials: The present study is registered at clinicaltrials.gov NCT03573609.
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