Critically IllACACIANCT06027008
Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults
A study testing Mechanical Insufflation-Exsufflation in people with Critically Ill, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The goal of this randomized feasibility trial is to evaluate the feasibility of Mechanical Insufflation-Exsufflation (MI-E) in invasively ventilated critically ill patients. The main question[s] it aims to answer are: Is MI-E feasible? Is MI-E safe? Participants in the intervention group will receive: MI-E Airway… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- Mechanical Insufflation-Exsufflation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Oct 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admission to one of the participating ICUs;
- receiving invasive mechanical ventilation via an endotracheal tube; and
- expected to need invasive ventilation for more than 48 hours from consideration for inclusion.
Who cannot join
- 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;
- known barotrauma;
Show all 10Show fewer
- known unstable spinal fractures;
- unsecured subarachnoidal haemorrhage;
- uncontrollable intracranial pressures; and
- any infection, or colonization with pathogens that requires strict aerogenic isolation. With an exception for patients in cohort isolation due to COVID-19.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam
About this study
Official title: Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults (ACACIA)-a Randomized Clinical Feasibility Trial
The goal of this randomized feasibility trial is to evaluate the feasibility of Mechanical Insufflation-Exsufflation (MI-E) in invasively ventilated critically ill patients.
The main question[s] it aims to answer are:
Read more
- Is MI-E feasible?
- Is MI-E safe?
Participants in the intervention group will receive:
- MI-E
- Airway secretions will be removed by endotracheal suctioning, as part of routine airway care.
- Manual hyperinflation will only be used when necessary in an emergency situation. Patients in the control group will receive endotracheal suctioning and manual hyperinflation when clinically indicated.
The primary outcome is the proportion of delivered MI-E sessions (2 times per calendar day a MI-E session of 3 x 3 cycles of an in- and exsufflation) per patient according to study protocol (feasibility). Secondary outcomes are the total number of serious adverse events in relation to MI-E (safety) and preliminary exploratory data on the need for airway care interventions and clinical outcomes including duration of invasive ventilation, length of stay in ICU and mortality (efficacy).
Read the detailed description
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.
MI-E settings are a 2-second insufflation and an immediate 2-second exsufflation. The cycles of the MI-E session will be performed with a positive and negative pressure of 40 cmH2O. The program is set up with the possibility of auto-triggering by the patient.
- Conditions
- Critically Ill
- Being tested
- Mechanical Insufflation-Exsufflation
- Keywords
- Mechanical insufflation-exsufflation, Cough Assist
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Insufflation-ExsufflationDevice
Also called Cough assist
MI-E will be applied twice a day in invasively ventilated patients. Since the severity of illness can change in the ICU, each day the attending nurse will check for clinical reasons to not apply MI-E with regard to safety. The following clinical criteria are predefined as a reason to refrain from MI-E at that day:
- severe ventilator instability (requiring > 12 cm H2O PEEP and dependency of > 60% FiO2);
- severe hemodynamic instability (a need for large and sustained increase in continuous administration of intravenous vasopressive medication that are adjusted on a frequent basis in each nursing shift);
- extra corporal membrane oxygenation (ECMO); and
- deeply sedated patient (RASS score ≤ -4).
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Insufflation-Exsufflation | Experimental | Invasively ventilated patients will receive MI-E until successful extubation or for a maximum of 7 days. MI-E will be given in the morning and afternoon each calendar day. Patients will be pre-oxygenated with FiO2 100% prior to disconnection from the ventilator; additional 15 litres oxygen can be added; A pre-set program is used: three times three cycles with a 2-second insufflation and an immediate 2-second exsufflation. The cycles of the MI-E session will be performed with a positive and negative pressure of 40 cmH2O. The program is set up with the possibility of auto-triggering by the patient. Receives: Device: Mechanical Insufflation-Exsufflation |
| Standard airway care | No intervention | Patients in the control group will receive usual airway care which includes endotracheal suctioning and manual hyperinflation used when indicated based on clinical signs as part of regular airway care. Care protocols for endotracheal suctioning and manual hyperinflation are predefined. As with the intervention arm, there will be no use of saline instillation during suctioning. Manual hyperinflation technique is described in the care protocol of the intensive care unit and ICU nurses are trained to perform this technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
intervention delivery
the proportion of complete sessions of MI-E every calender day (i.e. two MI-E sessions with 3 x 3 cycles of an in- and exsufflation) for all patients with a maximum of seven days of invasive ventilation
Measured: max. 7 days
Secondary outcomes (20)
incidence of pneumothorax (safety)
incidence of pneumothorax for which drainage is needed attributed to MI-E or to routine airway care procedures (i.e., manual hyperinflation)
Measured: max 7 days
incidence of endotracheal tube obstruction (safety)
incidence of endotracheal tube obstruction due to mucus plugging attributed to MI-E or regular airway care
Measured: max 7 days
incidence of severe hypoxemia (safety)
incidence of severe hypoxemia
Measured: max 7 days
incidence of severe hypotension (safety)
incidence of severe hypotension
Measured: max 7 days
incidence of severe hypertension (safety)
incidence of severe hypertension
Measured: max 7 days
Acceptability of Intervention Measure (AIM)
1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Response scale 1 (completely disagree) - 5 (completely agree)
Measured: through study completion, estimated one year
Intervention Appropriateness Measure (IAM)
1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Response scale 1 (completely disagree) - 5 (completely agree)
Measured: through study completion, estimated one year
Feasibility of Intervention Measure (FIM)
1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Response scale 1 (completely disagree) - 5 (completely agree)
Measured: through study completion, estimated one year
amount of time needed for MI-E (feasibility)
time needed to deliver the MI-E intervention
Measured: maximum of 1 hour per session
endotracheal suctioning (feasibility)
frequency of endotracheal suctioning per ventilation day
Measured: max. 7 days
MH (feasibility of MI-E)
frequency of manual hyperinflation
Measured: max. 7 days
VAP (efficacy MI-E sample size calculation)
incidence of ventilator associated pneumonia (VAP)
Measured: 28 days after inclusion
duration MV (efficacy MI-E sample size calculation)
duration of invasive ventilation
Measured: 28 days after inclusion
Mortality day 28 (efficacy MI-E sample size calculation)
mortality at day 28
Measured: up to day 28 from ICU admission
VFD-28 (efficacy MI-E sample size calculation)
ventilator-free days at day 28
Measured: 28 days after inclusion
ICU mortality (efficacy MI-E sample size calculation)
ICU mortality
Measured: 28 days after inclusion
hospital mortality (efficacy MI-E sample size calculation)
hospital mortality
Measured: 28 days after inclusion
supplemental oxygen (efficacy MI-E sample size calculation)
use of supplemental oxygen on ICU delivery after detubation
Measured: 28 days after inclusion
LOS ICU (efficacy MI-E sample size calculation)
length of stay in ICU
Measured: 28 days after inclusion
LOS hospital (efficacy MI-E sample size calculation)
length of stay in hospital
Measured: 28 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start30 Oct 2023
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Why it stopped: Low inclusion rate: 7 patients since October 2023. Strict exclusion criteria limited potential participants. Current machine is discontinued, the department will acquire a different cough machine, impacting training and materials.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized feasibility trial
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Frederique Paulus, RN, PHD, Principal investigator, Amsterdam UMC - intensive care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027008
- Sponsor's protocol ID
- ACACIA
- Acronym
- ACACIA
- Status last verified
- Dec 2024
- First submitted
- 6 Feb 2023
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no decision on a data sharing plan
Publications
Stilma W, Verweij L, Spek B, Scholte Op Reimer WJM, Schultz MJ, Paulus F, Rose L. Mechanical insufflation-exsufflation for invasively ventilated critically ill patients-A focus group study. Nurs Crit Care. 2023 Nov;28(6):923-930. doi: 10.1111/nicc.12858. Epub 2022 Dec 4.
PubMed 36464804Swingwood EL, Stilma W, Tume LN, Cramp F, Voss S, Bewley J, Ntoumenopoulos G, Schultz MJ, Scholte Op Reimer W, Paulus F, Rose L. The Use of Mechanical Insufflation-Exsufflation in Invasively Ventilated Critically Ill Adults. Respir Care. 2022 Aug;67(8):1043-1057. doi: 10.4187/respcare.09704. Epub 2022 May 24.
PubMed 35610033Rose L, Adhikari NK, Leasa D, Fergusson DA, McKim D. Cough augmentation techniques for extubation or weaning critically ill patients from mechanical ventilation. Cochrane Database Syst Rev. 2017 Jan 11;1(1):CD011833. doi: 10.1002/14651858.CD011833.pub2.
PubMed 28075489
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults (ACACIA)-a Randomized Clinical Feasibility Trial
- ClinicalTrials.gov ID
- NCT06027008
- Acronym / sponsor ID
- ACACIA / ACACIA
- Conditions
- Critically Ill
- Keywords
- Mechanical insufflation-exsufflation, Cough Assist
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low inclusion rate: 7 patients since October 2023. Strict exclusion criteria limited potential participants. Current machine is discontinued, the department will acquire a different cough machine, impacting training and materials.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized feasibility trial is to evaluate the feasibility of Mechanical Insufflation-Exsufflation (MI-E) in invasively ventilated critically ill patients.
The main question[s] it aims to answer are:
- Is MI-E feasible?
- Is MI-E safe?
Participants in the intervention group will receive:
- MI-E
- Airway secretions will be removed by endotracheal suctioning, as part of routine airway care.
- Manual hyperinflation will only be used when necessary in an emergency situation. Patients in the control group will receive endotracheal suctioning and manual hyperinflation when clinically indicated.
The primary outcome is the proportion of delivered MI-E sessions (2 times per calendar day a MI-E session of 3 x 3 cycles of an in- and exsufflation) per patient according to study protocol (feasibility). Secondary outcomes are the total number of serious adverse events in relation to MI-E (safety) and preliminary exploratory data on the need for airway care interventions and clinical outcomes including duration of invasive ventilation, length of stay in ICU and mortality (efficacy).
Detailed description
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.
MI-E settings are a 2-second insufflation and an immediate 2-second exsufflation. The cycles of the MI-E session will be performed with a positive and negative pressure of 40 cmH2O. The program is set up with the possibility of auto-triggering by the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Mechanical Insufflation-Exsufflation | Experimental | Device: Mechanical Insufflation-ExsufflationInvasively ventilated patients will receive MI-E until successful extubation or for a maximum of 7 days. MI-E will be given in the morning and afternoon each calendar day. Patients will be pre-oxygenated with FiO2 100% prior to disconnection from the ventilator; additional 15 litres oxygen can be added; A pre-set program is used: three times three cycles with a 2-second insufflation and an immediate 2-second exsufflation. The cycles of the MI-E session will be performed with a positive and negative pressure of 40 cmH2O. The program is set up with the possibility of auto-triggering by the patient. |
| Standard airway care | No intervention | –Patients in the control group will receive usual airway care which includes endotracheal suctioning and manual hyperinflation used when indicated based on clinical signs as part of regular airway care. Care protocols for endotracheal suctioning and manual hyperinflation are predefined. As with the intervention arm, there will be no use of saline instillation during suctioning. Manual hyperinflation technique is described in the care protocol of the intensive care unit and ICU nurses are trained to perform this technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- admission to one of the participating ICUs;
- receiving invasive mechanical ventilation via an endotracheal tube; and
- expected to need invasive ventilation for more than 48 hours from consideration for inclusion.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical Insufflation-ExsufflationAlso: Cough assistMI-E will be applied twice a day in invasively ventilated patients. Since the severity of illness can change in the ICU, each day the attending nurse will check for clinical reasons to not apply MI-E with regard to safety. The following clinical criteria are predefined as a reason to refrain from MI-E at that day: * severe ventilator instability (requiring > 12 cm H2O PEEP and dependency of > 60% FiO2); * severe hemodynamic instability (a need for large and sustained increase in continuous administration of intravenous vasopressive medication that are adjusted on a frequent basis in each nursing shift); * extra corporal membrane oxygenation (ECMO); and * deeply sedated patient (RASS score ≤ -4). | Device | Mechanical Insufflation-Exsufflation |
Primary outcome
intervention delivery
Time frame: max. 7 days
the proportion of complete sessions of MI-E every calender day (i.e. two MI-E sessions with 3 x 3 cycles of an in- and exsufflation) for all patients with a maximum of seven days of invasive ventilation
20 secondary outcomes
incidence of pneumothorax (safety)
Time frame: max 7 days
incidence of endotracheal tube obstruction (safety)
Time frame: max 7 days
incidence of severe hypoxemia (safety)
Time frame: max 7 days
incidence of severe hypotension (safety)
Time frame: max 7 days
incidence of severe hypertension (safety)
Time frame: max 7 days
Acceptability of Intervention Measure (AIM)
Time frame: through study completion, estimated one year
Intervention Appropriateness Measure (IAM)
Time frame: through study completion, estimated one year
Feasibility of Intervention Measure (FIM)
Time frame: through study completion, estimated one year
amount of time needed for MI-E (feasibility)
Time frame: maximum of 1 hour per session
endotracheal suctioning (feasibility)
Time frame: max. 7 days
MH (feasibility of MI-E)
Time frame: max. 7 days
VAP (efficacy MI-E sample size calculation)
Time frame: 28 days after inclusion
duration MV (efficacy MI-E sample size calculation)
Time frame: 28 days after inclusion
Mortality day 28 (efficacy MI-E sample size calculation)
Time frame: up to day 28 from ICU admission
VFD-28 (efficacy MI-E sample size calculation)
Time frame: 28 days after inclusion
ICU mortality (efficacy MI-E sample size calculation)
Time frame: 28 days after inclusion
hospital mortality (efficacy MI-E sample size calculation)
Time frame: 28 days after inclusion
supplemental oxygen (efficacy MI-E sample size calculation)
Time frame: 28 days after inclusion
LOS ICU (efficacy MI-E sample size calculation)
Time frame: 28 days after inclusion
LOS hospital (efficacy MI-E sample size calculation)
Time frame: 28 days after inclusion
Results and safety
The study was stopped early (reason given: Low inclusion rate: 7 patients since October 2023. Strict exclusion criteria limited potential participants. Current machine is discontinued, the department will acquire a different cough machine, impacting training and materials.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Background: PubMed 36464804Stilma W, Verweij L, Spek B, Scholte Op Reimer WJM, Schultz MJ, Paulus F, Rose L. Mechanical insufflation-exsufflation for invasively ventilated critically ill patients-A focus group study. Nurs Crit Care. 2023 Nov;28(6):923-930. doi: 10.1111/nicc.12858. Epub 2022 Dec 4.
- Background: PubMed 35610033Swingwood EL, Stilma W, Tume LN, Cramp F, Voss S, Bewley J, Ntoumenopoulos G, Schultz MJ, Scholte Op Reimer W, Paulus F, Rose L. The Use of Mechanical Insufflation-Exsufflation in Invasively Ventilated Critically Ill Adults. Respir Care. 2022 Aug;67(8):1043-1057. doi: 10.4187/respcare.09704. Epub 2022 May 24.
- Background: PubMed 28075489Rose L, Adhikari NK, Leasa D, Fergusson DA, McKim D. Cough augmentation techniques for extubation or weaning critically ill patients from mechanical ventilation. Cochrane Database Syst Rev. 2017 Jan 11;1(1):CD011833. doi: 10.1002/14651858.CD011833.pub2.
- Individual participant dataSharing planned: No. Currently, there is no decision on a data sharing plan
Related trials for Critically Ill
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederique Paulus, RN, PHD principal investigator
Amsterdam UMC - intensive care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Insufflation-Exsufflation in people with Critically Ill, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low inclusion rate: 7 patients since October 2023. Strict exclusion criteria limited potential participants. Current machine is discontinued, the department will acquire a different cough machine, impacting training and materials.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intervention delivery (time frame: max. 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06027008, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.