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Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults (ACACIA)

Primary Purpose

Critically Ill

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Mechanical Insufflation-Exsufflation
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Ill focused on measuring Mechanical insufflation-exsufflation, Cough Assist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Sites / Locations

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mechanical Insufflation-Exsufflation

Standard airway care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
incidence of endotracheal tube obstruction (safety)
incidence of endotracheal tube obstruction due to mucus plugging attributed to MI-E or regular airway care
incidence of severe hypoxemia (safety)
incidence of severe hypoxemia
incidence of severe hypotension (safety)
incidence of severe hypotension
incidence of severe hypertension (safety)
incidence of severe hypertension
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)
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)
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)
amount of time needed for MI-E (feasibility)
time needed to deliver the MI-E intervention
endotracheal suctioning (feasibility)
frequency of endotracheal suctioning per ventilation day
MH (feasibility of MI-E)
frequency of manual hyperinflation
VAP (efficacy MI-E sample size calculation)
incidence of ventilator associated pneumonia (VAP)
duration MV (efficacy MI-E sample size calculation)
duration of invasive ventilation
Mortality day 28 (efficacy MI-E sample size calculation)
mortality at day 28
VFD-28 (efficacy MI-E sample size calculation)
ventilator-free days at day 28
ICU mortality (efficacy MI-E sample size calculation)
ICU mortality
hospital mortality (efficacy MI-E sample size calculation)
hospital mortality
supplemental oxygen (efficacy MI-E sample size calculation)
use of supplemental oxygen on ICU delivery after detubation
LOS ICU (efficacy MI-E sample size calculation)
length of stay in ICU
LOS hospital (efficacy MI-E sample size calculation)
length of stay in hospital

Full Information

First Posted
February 6, 2023
Last Updated
August 30, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT06027008
Brief Title
Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults
Acronym
ACACIA
Official Title
Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults (ACACIA)-a Randomized Clinical Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill
Keywords
Mechanical insufflation-exsufflation, Cough Assist

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized feasibility trial
Masking
None (Open Label)
Masking Description
Due to the nature of the intervention, blinding of healthcare professionals and any research personnel involved in the delivery of the intervention is not possible.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mechanical Insufflation-Exsufflation
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard airway care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Mechanical Insufflation-Exsufflation
Other Intervention Name(s)
Cough assist
Intervention Description
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).
Primary Outcome Measure Information:
Title
intervention delivery
Description
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
Time Frame
max. 7 days
Secondary Outcome Measure Information:
Title
incidence of pneumothorax (safety)
Description
incidence of pneumothorax for which drainage is needed attributed to MI-E or to routine airway care procedures (i.e., manual hyperinflation)
Time Frame
max 7 days
Title
incidence of endotracheal tube obstruction (safety)
Description
incidence of endotracheal tube obstruction due to mucus plugging attributed to MI-E or regular airway care
Time Frame
max 7 days
Title
incidence of severe hypoxemia (safety)
Description
incidence of severe hypoxemia
Time Frame
max 7 days
Title
incidence of severe hypotension (safety)
Description
incidence of severe hypotension
Time Frame
max 7 days
Title
incidence of severe hypertension (safety)
Description
incidence of severe hypertension
Time Frame
max 7 days
Title
Acceptability of Intervention Measure (AIM)
Description
1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Response scale 1 (completely disagree) - 5 (completely agree)
Time Frame
through study completion, estimated one year
Title
Intervention Appropriateness Measure (IAM)
Description
1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Response scale 1 (completely disagree) - 5 (completely agree)
Time Frame
through study completion, estimated one year
Title
Feasibility of Intervention Measure (FIM)
Description
1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Response scale 1 (completely disagree) - 5 (completely agree)
Time Frame
through study completion, estimated one year
Title
amount of time needed for MI-E (feasibility)
Description
time needed to deliver the MI-E intervention
Time Frame
maximum of 1 hour per session
Title
endotracheal suctioning (feasibility)
Description
frequency of endotracheal suctioning per ventilation day
Time Frame
max. 7 days
Title
MH (feasibility of MI-E)
Description
frequency of manual hyperinflation
Time Frame
max. 7 days
Title
VAP (efficacy MI-E sample size calculation)
Description
incidence of ventilator associated pneumonia (VAP)
Time Frame
28 days after inclusion
Title
duration MV (efficacy MI-E sample size calculation)
Description
duration of invasive ventilation
Time Frame
28 days after inclusion
Title
Mortality day 28 (efficacy MI-E sample size calculation)
Description
mortality at day 28
Time Frame
up to day 28 from ICU admission
Title
VFD-28 (efficacy MI-E sample size calculation)
Description
ventilator-free days at day 28
Time Frame
28 days after inclusion
Title
ICU mortality (efficacy MI-E sample size calculation)
Description
ICU mortality
Time Frame
28 days after inclusion
Title
hospital mortality (efficacy MI-E sample size calculation)
Description
hospital mortality
Time Frame
28 days after inclusion
Title
supplemental oxygen (efficacy MI-E sample size calculation)
Description
use of supplemental oxygen on ICU delivery after detubation
Time Frame
28 days after inclusion
Title
LOS ICU (efficacy MI-E sample size calculation)
Description
length of stay in ICU
Time Frame
28 days after inclusion
Title
LOS hospital (efficacy MI-E sample size calculation)
Description
length of stay in hospital
Time Frame
28 days after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frederique Paulus, RN, PHD
Phone
+31-20-5669111
Email
f.paulus@amsterdamumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Willemke Stilma, RN, MSc, LLM
Phone
+31-20-5669111
Email
w.stilma@amsterdamumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederique Paulus, RN, PHD
Organizational Affiliation
Amsterdam UMC - intensive care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Willemke Stilma, RN, MSc, LLM
Phone
+31-20-5669111
Email
w.stilma@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Frederique Paulus, PHD
Phone
+31-20-5669111
Email
f.paulus@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Marcus J Schultz, MD, PHD
First Name & Middle Initial & Last Name & Degree
Frederique Paulus, RN, PHD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Currently, there is no decision on a data sharing plan
Citations:
PubMed Identifier
36464804
Citation
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. 2022 Dec 4. doi: 10.1111/nicc.12858. Online ahead of print.
Results Reference
background
PubMed Identifier
35610033
Citation
Swingwood 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.
Results Reference
background
PubMed Identifier
28075489
Citation
Rose 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.
Results Reference
background

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Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults

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