Respiratory FailureNCT03178565
The Effects of Mechanical Insufflation-exsufflation on Airway Mucus Clearance in the ICU
A study testing Mechanical insufflation-exsufflation and Standard Respiratory Physiotherapy in people with Respiratory Failure, run by Hospital Moinhos de Vento at 1 site in Brazil.
Trial summary
The present study aims to evaluate the effect of mechanical insufflation-exsufflation on airway mucus clearance among mechanically ventilated ICU patients. A parallel group randomized clinical trial will be conducted in a single mixed medical-surgical ICU of a tertiary hospital in Southern Brazil. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Mechanical insufflation-exsufflation and Standard Respiratory Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2016to Nov 2017
- 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
- Age ≥ 18 years;
- Admission to the ICU
- Length of mechanical ventilation > 24 hours
- Stable ventilatory and hemodynamic status defined by positive end- expiratory pressure ≤ 8 cm H2O, inspiratory oxygen fraction ≤ 40%, ratio of arterial oxygen partial pressure to fractional inspired oxygen ≥ 150, respiratory rate ≤ 35 breaths per minute, heart rate ≤ 130 beats per minute and systolic blood pressure between 90 and 160 mmHg.
Who cannot join
- Patients with primary neuromuscular disease.
- Patients in exclusive paliative care.
- Patients with contraindications to the use of mechanical insufflation- Exsufflation device.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035001
Cassiano Teixeira, MD, 555133143387, cassiano.rush@gmail.com
Marcio Camillis
About this study
Official title: The Effects of Mechanical Insufflation-exsufflation for Airway Mucus Clearance Among Mechanically Ventilated ICU Patients: a Randomized Trial
The present study aims to evaluate the effect of mechanical insufflation-exsufflation on airway mucus clearance among mechanically ventilated ICU patients. A parallel group randomized clinical trial will be conducted in a single mixed medical-surgical ICU of a tertiary hospital in Southern Brazil. Adult ICU patients with a length of mechanical ventilation >24 hours will be evaluated for eligibility. Patients will be randomized in a 1:1 ratio to receive respiratory physiotherapy using a mechanical insufflation-exsufflation device (intervention group) or standard respiratory physiotherapy without the use of the mechanical insufflation-exsufflation device (control group). The primary outcome is the amount of aspirated respiratory mucus (weight in grams) 5 minutes after the finish of respiratory physiotherapy.
- Conditions
- Respiratory Failure
- Being tested
- Mechanical insufflation-exsufflation, Standard Respiratory Physiotherapy
- Keywords
- Respiratory Failure, Mechanical Ventilation, Mechanical insufflation-exsufflation, Airway mucus clearance
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical insufflation-exsufflationOther
Also called CoughAssist
The mechanical insufflation-exsufflation device will be connected in the orotracheal tube. Four series of insufflation-exsufflation will be conducted. Each serie will be composed by 10 cycles of alternated insufflation (40 cmH2O) and exsufflation (- 40 cmH2O).
Standard Respiratory PhysiotherapyOther
Standard chest physiotherapy will be conducted through bilateral thoracic maneuvers (percussion and vibration) followed by manual hyperinflation using a manual resuscitator bag.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Respiratory physiotherapy using a mechanical insufflation-exsufflation device (CoughAssist) Receives: Other: Mechanical insufflation-exsufflation |
| Control Group | Active comparator | Respiratory physiotherapy according standard of care - without the use of a mechanical insufflation-exsufflation device. Receives: Other: Standard Respiratory Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of aspirated secretion
Single measure of weight in grams of the aspirated secretion 5 minutes after the study intervention (mechanical insufflation-exsufflation or standard respiratory physiotherapy).
Measured: This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment.
Secondary outcomes (2)
Static lung compliance
Single measure of the static lung compliance in mL/cm H2O
Measured: This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment.
Airway resistance
Single measure of the airway resistance in cm H2O/L/s
Measured: This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study startDec 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mechanically ventilated patients will be randomized to receive respiratory physiotherapy using a mechanical insufflation-exsufflation device (intervention group) or to receive standard respiratory physiotherapy without the use of a mechanical insufflation-exsufflation device (control group).
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Moinhos de Vento
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Augusto Savi, Hospital Moinhos de Vento
- Investigators
- Marcio Camillis, Principal investigator, Hospital Moinhos de Vento
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178565
- Sponsor's protocol ID
- CoughAssist trial
- Status last verified
- Jun 2017
- First submitted
- 21 Apr 2017
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ferreira de Camillis ML, Savi A, Goulart Rosa R, Figueiredo M, Wickert R, Borges LGA, Galant L, Teixeira C. Effects of Mechanical Insufflation-Exsufflation on Airway Mucus Clearance Among Mechanically Ventilated ICU Subjects. Respir Care. 2018 Dec;63(12):1471-1477. doi: 10.4187/respcare.06253. Epub 2018 Jul 17.
PubMed 30018175
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mechanical Insufflation-exsufflation for Airway Mucus Clearance Among Mechanically Ventilated ICU Patients: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03178565
- Acronym / sponsor ID
- CoughAssist trial
- Conditions
- Respiratory Failure
- Keywords
- Respiratory Failure, Mechanical Ventilation, Mechanical insufflation-exsufflation, Airway mucus clearance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Hospital Moinhos de VentoUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 7 Jun 2017 (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 present study aims to evaluate the effect of mechanical insufflation-exsufflation on airway mucus clearance among mechanically ventilated ICU patients. A parallel group randomized clinical trial will be conducted in a single mixed medical-surgical ICU of a tertiary hospital in Southern Brazil. Adult ICU patients with a length of mechanical ventilation >24 hours will be evaluated for eligibility. Patients will be randomized in a 1:1 ratio to receive respiratory physiotherapy using a mechanical insufflation-exsufflation device (intervention group) or standard respiratory physiotherapy without the use of the mechanical insufflation-exsufflation device (control group). The primary outcome is the amount of aspirated respiratory mucus (weight in grams) 5 minutes after the finish of respiratory physiotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mechanically ventilated patients will be randomized to receive respiratory physiotherapy using a mechanical insufflation-exsufflation device (intervention group) or to receive standard respiratory physiotherapy without the use of a mechanical insufflation-exsufflation device (control group).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Mechanical insufflation-exsufflationRespiratory physiotherapy using a mechanical insufflation-exsufflation device (CoughAssist) |
| Control Group | Active comparator | Other: Standard Respiratory PhysiotherapyRespiratory physiotherapy according standard of care - without the use of a mechanical insufflation-exsufflation device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Admission to the ICU
- Length of mechanical ventilation > 24 hours
- Stable ventilatory and hemodynamic status defined by positive end- expiratory pressure ≤ 8 cm H2O, inspiratory oxygen fraction ≤ 40%, ratio of arterial oxygen partial pressure to fractional inspired oxygen ≥ 150, respiratory rate ≤ 35 breaths per minute, heart rate ≤ 130 beats per minute and systolic blood pressure between 90 and 160 mmHg.
Key exclusion criteria (3 listed)
- Patients with primary neuromuscular disease.
- Patients in exclusive paliative care.
- Patients with contraindications to the use of mechanical insufflation- Exsufflation device.
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: CoughAssistThe mechanical insufflation-exsufflation device will be connected in the orotracheal tube. Four series of insufflation-exsufflation will be conducted. Each serie will be composed by 10 cycles of alternated insufflation (40 cmH2O) and exsufflation (- 40 cmH2O). | Other | Intervention Group |
| Standard Respiratory PhysiotherapyStandard chest physiotherapy will be conducted through bilateral thoracic maneuvers (percussion and vibration) followed by manual hyperinflation using a manual resuscitator bag. | Other | Control Group |
Primary outcome
Amount of aspirated secretion
Time frame: This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment.
Single measure of weight in grams of the aspirated secretion 5 minutes after the study intervention (mechanical insufflation-exsufflation or standard respiratory physiotherapy).
2 secondary outcomes
Static lung compliance
Time frame: This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment.
Airway resistance
Time frame: This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Derived from this study: PubMed 30018175Ferreira de Camillis ML, Savi A, Goulart Rosa R, Figueiredo M, Wickert R, Borges LGA, Galant L, Teixeira C. Effects of Mechanical Insufflation-Exsufflation on Airway Mucus Clearance Among Mechanically Ventilated ICU Subjects. Respir Care. 2018 Dec;63(12):1471-1477. doi: 10.4187/respcare.06253. Epub 2018 Jul 17.
- Individual participant dataSharing planned: No
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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.
Marcio Camillis principal investigator
Hospital Moinhos de Vento
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 and Standard Respiratory Physiotherapy in people with Respiratory Failure, run by Hospital Moinhos de Vento at 1 site in Brazil.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Jun 2017. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcio Camillis (55-51-996569173, marciocamillis@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of aspirated secretion (time frame: This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment.). 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 NCT03178565, which also lists 1 linked publication.
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 7 Jun 2017.