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Mechanical insufflation-exsufflation (Cough Assist) in Critically Ill Adults: A randomized controlled trial

Mechanical insufflation-exsufflation (Cough Assist) in Critically Ill Adults: A randomized controlled trial - ACACIA-trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52221
Enrollment
50
Registered
2022-11-23
Start date
2024-05-08
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

airway clearance - mucociliary clearance respiratory secretion accumulation

Interventions

Bedside nurses, trained in using the MI-E device, will apply MI-E sessions at two moments per calendar day (morning and afternoon) for a maximum of 7 days while a patient is invasively ventilated. A

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • admission to one of the participating ICUs; and • intubated with an endotracheal tube; and • expected to need invasive ventilation for more than 48 hours from consideration for inclusion.

Exclusion criteria

Exclusion criteria: age

Design outcomes

Primary

MeasureTime frame
The primary outcome is the proportion of delivered MI-E sessions (2 times a MI-E session of 3 cycles per calendar day) per patient according to study protocol (feasibility).

Secondary

MeasureTime frame
Secondary outcomes are the total number of serious adverse events (incidence of pneumothorax and serious hemodynamic of pulmonary instability) in relation to MI-E (safety) and preliminary exploratory data on clinical outcomes including duration of invasive ventilation, length of stay in ICU and mortality (efficacy).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)