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Evaluation of the Safety and Effectiveness of the BCS3 Bionic Cough Simulator for Secretion Clearance in Patients with Invasive Mechanical Ventilation: A Prospective, Multicenter, Randomized, Parallel, Positive-Controlled Efficacy Clinical Trial

Evaluation of the Safety and Effectiveness of the BCS3 Bionic Cough Simulator for Secretion Clearance in Patients with Invasive Mechanical Ventilation: A Prospective, Multicenter, Randomized, Parallel, Positive-Controlled Efficacy Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080792
Enrollment
Unknown
Registered
2024-02-07
Start date
2024-03-12
Completion date
Unknown
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

none

Interventions

Experimental group:Phlegm expectoration treatment was performed three times with an interval of more than 4 hours between treatments. Each treatment consisted of 6 groups, with 6 coughs in each group.
mode set to "automatic"
daytime cycle set at 15-30 minutes, and nighttime cycle set at 60-120 minutes, with a cough count set at 10 times. Note: Daytime refers to the period from 30 minutes after the first treatment to befo
Control group:Phlegm expectoration treatment was performed three times with an interval of more than 4 hours between treatments. Each treatment consisted of 6 groups, with 6 coughs in each group. The

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1. Age = 18 years old, gender is not limited; 2. Establishment of artificial airway (endotracheal intubation or tracheotomy) with the expectation of mechanical ventilation for at least 24 hours; 3. The estimated amount of expectoration in the 24 hours before enrollment is = 10ml; 4. The subject or his/her legal representative has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.History of bullous emphysema, pneumothorax, or mediastinal emphysema without appropriate drainage; 2.Chest trauma or surgery within the past month; 3.History of acute cerebral hemorrhage within the past two weeks; 4.Acute myocardial infarction or heart function grade IV within the past two weeks; 5.Uncorrected hypotension, with systolic blood pressure persistently below 90 mmHg despite appropriate treatment with vasopressors; 6.Uncontrolled malignant arrhythmias, including supraventricular tachycardia, ventricular tachycardia, ventricular fibrillation, and third-degree atrioventricular block; 7.Participation in any other clinical trials of drugs or medical devices within three months; 8.Other patients researchers believe are inappropriate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
The total amount of expectoration in 24 hours;

Secondary

MeasureTime frame
Improvement of Blood Oxygen Saturation;Respiratory Mechanics Parameters;The evaluation of instrument performance;

Countries

China

Contacts

Public ContactQingyuan Zhan

China-Japan Friendship Hospital

zhanqy0915@163.com+86 139 1178 5957

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026