Skip to content

A Study on the Application of Mechanical Insufflation-Exsufflation (MI-E) Combined with Manual Hyperinflation (MHI) in Critically ill Patients Receiving Mechanical Ventilation After Stroke

A Study on the Application of Mechanical Insufflation-Exsufflation (MI-E) Combined with Manual Hyperinflation (MHI) in Critically ill Patients Receiving Mechanical Ventilation After Stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126749
Enrollment
Unknown
Registered
2026-06-15
Start date
2026-06-15
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

stroke

Interventions

Control group:Mechanical Insufflation-Exsufflation
Experimental group:Mechanical Insufflation-Exsufflation

Sponsors

Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Definitive diagnosis of stroke (including ischemic stroke, cerebral hemorrhage or subarachnoid hemorrhage, etc.), and stroke-related neurological dysfunction as the main underlying disease; 2.Tracheostomy artificial airway has been established, and currently receiving invasive mechanical ventilation support (including control/assisted control, SIMV, PSV, CPAP/PS, etc., spontaneous breathing can exist, but still ventilator-assisted ventilation), and is expected to be managed by a ventilator and undergo airway clearance treatment in the next 5 days; 3.Unable to actively cooperate with sputum training, pulmonary rehabilitation, or directive breathing maneuvers due to impaired consciousness, severe aphasia, cognitive impairment, or obvious neurological deficits; 4.Presence of secretion retention (eg, viscous sputum, frequent sputum suction, weak cough, or pronounced sputum sounds); 5.Lung ultrasound before the first study intervention showed a certain degree of decrease in lung air content, and the 12-zone lung ultrasound score (LUS) was used, with a total LUS score of >= 6 points and at least one lung area score of >=2 points; 6.Vital signs are relatively stable and tolerable to MIE, MHI point-of-care therapy; 7. Age >= 18.

Exclusion criteria

Exclusion criteria: 1.Combined with severe chronic obstructive pulmonary disease, or at clear risk of severe expiratory airflow restriction or dynamic hyperinflation; 2.Combined with acute severe asthma, active bronchospasm, or recent significant airway hyperresponsiveness; 3.Those who are not suitable for MIE or MHI due to pulmonary bullae, undrained pneumothorax, recent barotrauma, etc; 4.Active hemoptysis, recent severe airway or chest injury; 5.Severe hemodynamic instability (requiring continuous high-dose vasopressors or presence of refractory arrhythmias); 6.Significantly increased intracranial pressure, high risk of cerebral herniation, or clinical judgment that the intervention of this study is not appropriate;

Design outcomes

Primary

MeasureTime frame
Lung ultrasound score (LUS);

Secondary

MeasureTime frame
Wet weight of sputum;Occurrence of adverse events;Respiratory compliance;Oxygenation index and sputum suction frequency;Mechanical ventilation related outcomes;

Countries

China

Contacts

Public ContactJunyi Xiang

Zhejiang Provincial People's Hospital

xjy980103@163.com+86 13547877258

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 29, 2026