The primary objective of this study is to evaluate the feasibility of MI-E in invasively ventilated critically ill patients. The secondary objective is to evaluate safety and explore data on the efficacy of MI-E in invasively ventilated critically…
ID
Source
Brief title
Condition
- Other condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Health condition
airway clearance - mucociliary clearance
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
In invasively ventilated critically ill patients, removal of airway secretions
is typically performed by mimicking a cough followed by endotracheal
suctioning. A cough can be mimicked by applying manual hyperinflation, which is
an uncontrolled maneuver with high risks. Another way to mimic a cough is by
means of mechanical insufflation exsufflation (MI-E), which is more controlled,
and by that probably safer and more effecious than manual hyperinflation. Also,
MI-E could be more comfortable for the patient. It is uncertain, however,
whether MI-E is feasible, safe, and effective in invasively ventilated
critically ill patients.
Study objective
The primary objective of this study is to evaluate the feasibility of MI-E in
invasively ventilated critically ill patients.
The secondary objective is to evaluate safety and explore data on the efficacy
of MI-E in invasively ventilated critically ill patients with regard to need
for airway care interventions, duration of invasive ventilation and mortality.
Study design
Multicentre randomized clinical feasibility trial.
Intervention
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. Airway secretions are removed by
endotracheal suctioning, as part of routine airway care. Manual hyperinflation
will only be used when necessary in an emergency situation.
Study burden and risks
The technique currently used to mimic a cough for invasively ventilated
critically ill patients is manual hyperinflation. Manual hyperinflation could
be accompanied or replaced by MI-E as part of regular airway care. MI-E could
bring risks associated with the procedure due to disconnection from the
ventilator and the settings of MI-E. MI-E could be associated with possible
benefits due to a more controlled way to mimic a cough while insufflated and
exsufflated pressures are applied according to the defined settings.
Additionally the need for deeper tracheal suctioning may be reduced.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
age <18 years;
already use of MI-E before hospital admission, i.e., at home; known presence of
bullous emphysema; known bronchopleural fistula; known pneumothorax or
pneumomediastinum; known rib fractures or unstable spinal fractures; unsecured
subarachnoidal haemorrhage; uncontrollable intracranial pressures. Patients in
aerogenic isolation, apart from cohort isolation due to COVID-19, are also
excluded.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76195.018.22 |