Clinical trial to verify the safety of an automatic electric airway suction system: a multicenter prospective randomized study

Abstract

Abstract Background Acute lung injury and respiratory failure in patients in the intensive care unit (ICU) present challenges owing to varied factors. Manual suctioning, which is the current standard, burdens healthcare professionals and poses risks. The Lmeca.A1000 automatic suction device offers an innovative solution to this problem. This study aimed to evaluate the safety of this device. Methods This prospective, multicenter, randomized trial compared automatic and manual suction in ICU patients. Mucosal injury and pneumonia were assessed using bronchoscopy and monitoring. Mechanical stability and adverse events were also evaluated. Results In total, 117 critically ill adults were screened: 56 in the experimental group and 53 in the control group completing the study. No significant difference in mucosal injury was found at 3 or 7 days after treatment (p = 0.871, and 0.750). The incidence of VAP over 2 weeks was 5.36% in the experimental group and 1.89% in the control group, not significantly different (p = 0.582). Adverse events occurred in 14.3 and 13.2%, respectively, with no significant difference (p = 0.870). The incidence of clinical trial device malfunction within 3 days of application was 0.03% and within 2 weeks of follow-up was 0.02%. Conclusions This study evidenced the non-inferiority of the automatic suction device to the manual method in terms of safety. The adoption of an automated system could alleviate the workload of healthcare professionals while maintaining effective airway management.

Keywords

• Airway management
• Suction drainage
• Respiratory mucosa
• Pneumonia
• Ventilator-associated
• Equipment and supplies