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Clinical Trial
. 2025 Mar 24:18:201-212.
doi: 10.2147/MDER.S499924. eCollection 2025.

A Novel Supraglottic Suction Device in Mechanically Ventilated Patients: A Randomized Controlled Trial

Mauricio Orozco-Levi  1   2   3 , Diana Carolina Tiga-Loza  1   3 , Orlando Aya  4 , Carlos Fernando Reyes  4 , Diana Cáceres-Rivera  1 , Angela Espitia  1 , Diana Rey  1 , Karen Patricia Pedrozo Arias  1   3 , Camilo Pizarro  5 , Sandra M Sanabria-Barrera  6 , Norma Serrano-Díaz  7 , Victor R Castillo  8 , Alba Ramírez-Sarmiento  1   2   7
Affiliations
Clinical Trial

A Novel Supraglottic Suction Device in Mechanically Ventilated Patients: A Randomized Controlled Trial

Mauricio Orozco-Levi et al. Med Devices (Auckl). .

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 (P25;P75: 55;569; +50%). The device did not induce adverse events.

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.

Keywords: critical care; intratracheal intubation; mechanical ventilation; pneumonia; salivation; suction.

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Conflict of interest statement

Dr Mauricio Orozco-Levi reports a patent SUPRAtube. This device has received a patent as a utility model licensed to (ref. NC2016/0002059 Resolution 466). Dr Alba Ramírez-Sarmiento reports a patent NC2016/0002059 Dispositivo médico de aspiración supraglótica en pacientes ventilados mecánicamente licensed to Resolution 466 of the Superintendence of Industry and Commerce, Colombia. The authors report no other conflicts of interest in this work. An abstract of this paper was presented at the ERS Congress 2019 (Madrid, Spain) - Late Breaking Abstract conference talk, with interim findings. The abstract was published in the European Respiratory Journal 2019, with DOI https://doi.org/10.1183/13993003.congress-2019.RCT5098.

Figures

Figure 1
Figure 1
Three-dimensional images showing the three functional components of the SUPRAtube. (A) Shows an enlarged view of the elastomeric ellipsoid device which is designed as the intracavitary element inserted through the mouth or nose and advanced to the supraglottis for continuous negative pressure aspiration of secretions; (B–D) Show the flexible probe and the universal connector for the vacuum pressure source at the other end of the device. Details of the development and fabrication of the device are described in both the body of the manuscript and reference 11 (Ramírez.-Sarmiento A., et al, Med Devices 2021;14:287–297).
Figure 2
Figure 2
Study Flow Diagram.
Figure 3
Figure 3
Efficacy of continuous supraglottic suction with the SUPRAtube device in mechanically ventilated patients. Results are expressed in terms of the net weight of total aspirated fluid (y-axis) in the two study groups, the control arm and the SUPRAtube group (x-axis). For a review of the normalized values per unit of time, refer to Table 2.
Figure 4
Figure 4
Images obtained during videoendoscopic evaluations of two of the patients in whom the SUPRAtube device was inserted and put into operation. (A) Ellipsoid elastomeric component of the SUPRAtube as seen endoscopically when placed in the supraglottic area of intubated patients; in the contour-drawn rendered figure, the elastomeric component is highlighted as the red shaded area; (B and C) contact of the ellipsoid elastomeric component of the SUPRAtube with the postero-lateral wall of the supraglottis; (C) orotracheal tube for mechanical ventilation; (D) anterior wall of the supraglottis; (*): visible foramina of the suction elastomeric component; (#): left vocal cord.
See this image and copyright information in PMC

References

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