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Heart DiseasesNCT04583371

The Use of Pulmonary Hyperinflation With the Mechanical Ventilator in Cardiac Patients

A study testing MECHANICAL PULMONARY HYPERINFLUATION in people with Heart Diseases, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Mechanical ventilation (MV) is used to reduce work and reverse or prevent fatigue of the respiratory muscles, decrease oxygen consumption and maintain gas exchange. In addition to the benefits given to patients undergoing MV, there is a high risk of accumulating bronchial secretions, related to pathology and / or… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Diseases
What is being tested?
MECHANICAL PULMONARY HYPERINFLUATION
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteBrazil
Study dates
1 Jul 2020to 1 Mar 2021
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

  • Interned in the Post-Operative Unit (UPO), Intensive Care Center (ICU) and Emergency.
  • Using invasive mechanical ventilation for more than 48 hours.
  • Hemodynamically stable (MAP 60-120 mmHg).

Who cannot join

  • Diagnosis of ventilator-associated pneumonia.
  • Individuals with pneumothorax and undrained hemothorax.
  • Subcutaneous emphysema.
  • Patients with peak pressure> 40 cmH2O.
  • Patients diagnosed with neurological disease within 72 hours.

Trial locations and contacts

1 site in 1 country.

Marcela Olixewski, Bacharel contact

55 51998078004

marcelapolixewski@hotmail.com

Daiane Pereira, Bacharel contact

55 51 999187736

daiane.silvpereira@gmail.com

Brazil1 site, 1 recruiting
  • Instituto de Cardiologia

    Porto Alegre, Rio Grande do Sul, 90040371

    Marcela Olixewski, Bacharel, 55 51 998078004, marcelapolixewski@hotmail.com

    Daiane Pereira, Bacharel, 55 51 999187736, daianesilvpereira@gmail.com

    Recruiting

Other trials in Brazil

About this study

Official title: Effect of the Use of Pulmonary Hyperinflation With Mechanical Ventilator Plus Aspiration Versus Isolated Tracheal Aspiration in Bronchial Hygiene in Patients With Heart Disease

Mechanical ventilation (MV) is used to reduce work and reverse or prevent fatigue of the respiratory muscles, decrease oxygen consumption and maintain gas exchange. In addition to the benefits given to patients undergoing MV, there is a high risk of accumulating bronchial secretions, related to pathology and / or therapeutic intervention. Pulmonary hyperinflation is widespread in patients in intensive care centers (ICUs) as a bronchial hygiene therapy, being used in 40% of 64 Australian ICUs as demonstrated by Dennis et al., Through contact with physical therapists. Mechanical hyperinflation associated with tracheal aspiration is able to increase the amount of secretion aspirated when compared to isolated aspiration in patients undergoing mechanical ventilation. To assess whether the pulmonary hyperinflation maneuver with the mechanical ventilator, compared to isolated tracheal aspiration, increases the removal of secretions. To evaluate whether the use of the pulmonary hyperinflation maneuver in the mechanical ventilator is hemodynamically stable through the collection in two moments of the variables of heart rate (HR), mean arterial pressure (MAP), peripheral saturation (SpO2), respiratory rate (RF) that will be analyzed from the postoperative unit's multiparametric monitor.

Evaluate the change in respiratory mechanics through collection in two moments after the mechanical hyperinflation technique through dynamic compliance (Cdyn), tidal air volume (VAC), peak pressure (Ppico). The population will consist of patients from the Post-Operative Unit (UPO), from the Institute of Cardiology, of both sexes, over 18 years old, mechanically ventilated and the sample consisting of 50 individuals. These will be submitted to the use of the pulmonary hyperinflation maneuver in the mechanical ventilator. Randomized crossover clinical trial.

Read the detailed description

Mechanical ventilation (MV) is used to reduce work and reverse or prevent fatigue of the respiratory muscles, decrease oxygen consumption and maintain gas exchange. In addition to the benefits given to patients undergoing MV, there is a high risk of accumulating bronchial secretions, related to pathology and / or therapeutic intervention. Pulmonary hyperinflation is widespread in patients in intensive care centers (ICUs) as a bronchial hygiene therapy, being used in 40% of 64 Australian ICUs as demonstrated by Dennis et al., Through contact with physical therapists. Mechanical hyperinflation associated with tracheal aspiration is able to increase the amount of secretion aspirated when compared to isolated aspiration in patients undergoing mechanical ventilation.

To evaluate whether the use of the pulmonary hyperinflation maneuver in the mechanical ventilator is hemodynamically stable through the collection in two moments of the heart rate (HR), mean arterial pressure (MAP), peripheral saturation (SpO2), respiratory rate (RF) variables that will be analyzed from the postoperative unit's multiparametric monitor.

Evaluate the change in respiratory mechanics through collection in two moments after the mechanical hyperinflation technique through dynamic compliance (Cdyn), tidal air volume (VAC), peak pressure (Ppico). The population will consist of patients from the Post-Operative Unit (UPO), unit intensive care (UCI) and emergency room, from the Institute of Cardiology, of both sexes, over 18 years old, mechanically ventilated more than 48 hours and the sample consisting of 50 individuals. These will be submitted to the use of the pulmonary hyperinflation maneuver in the mechanical ventilator.

This is a randomized crossover clinical trial in which the individuals selected for the study will be randomized to receive isolated tracheal aspiration (Control Group) and pulmonary hyperinflation through the mechanical ventilator associated with tracheal aspiration (Intervention Group). Randomization will be performed through the randomization.com website by a 1: 1 crossed block, allocating the patient to one of the groups and, after 24 hours, another technique will be performed. In addition, a control aspiration will be performed 2 hours before both techniques.

For basal aspiration, the patient will be placed in the supine position with the head elevated at 30º, will be submitted to a single aspiration with a size 12 probe (Mark Med), with a vacuum adjusted to -40cmH2O of pressure, with basic asepsis care being maintained for performing the technique35.

In the control group, patients will be ventilated for 1 minute with 100% inspired oxygen (FiO2), followed by three aspirations for 15 seconds and with an interval of 30 seconds.

In the participants of the intervention group, the calculation of the ideal tidal volume for each patient will be performed, after which they will be positioned in the supine position, the head elevated to 30º in assisted pressure-controlled ventilation mode, increasing 10 cmH2O in inspiratory pressure and, in assisted ventilation mode. controlled by volume, we will increase 50% of the tidal volume for a period of 10 minutes, observing the Ppeak that cannot exceed 40 cmH2O and the drive pressure that cannot exceed 15 cmH2O in both ventilation modes, and then a new aspiration will be performed. in the same way as the control group. The hemodynamics data will be taken from the multiparametric monitor of the hospitalization units (philips) and the respiratory mechanics data will be collected from the mechanical ventilator screen (Servo S; Drager; Newport), before and after the techniques. The volume of secretion will be stored in the collection flask (Water Seal 120 ml) and weighed using a high precision scale, discounting the weight of the collection flask.

The Informed Consent Form (ICF) will be signed by the responsible family member, containing information and explanations about the present study and the researcher will be available to explain doubts and questions at the time and afterwards through the telephone present at the ICF. All procedures will be performed under the supervision of the physiotherapist at the hospital. It is understood that this research may offer a minimal risk to volunteers, according to resolution 466/12 of the National Health Council, since they may have some discomfort and / or their hemodynamic situation altered by the application of the aforementioned physical therapy technique. As a counterpart, in case the predicted risk occurs, the subjects will receive all the necessary care from the researcher, together with the unit's physiotherapist and medical team, if necessary. The benefits to the subjects refer to the possibility of improving their respiratory function and bronchial hygiene.

Conditions
Heart Diseases
Being tested
MECHANICAL PULMONARY HYPERINFLUATION
Keywords
PHYSIOTHERAPY, Mechanical Ventilation
Medical subject headings
Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MECHANICAL PULMONARY HYPERINFLUATIONOther

    For basal aspiration, the patient will be placed in the supine position with the head elevated at 30º, will be submitted to a single aspiration with a size 12 probe (Mark Med), with a vacuum adjusted to -40cmH2O of pressure, with basic asepsis care being maintained for performing the technique. In the participants of the intervention group, the calculation of the ideal tidal volume of each patient will be performed, after which they will be positioned in the same way as baseline aspiration, in assisted-controlled pressure ventilation, increasing 10 cmH2O in inspiratory pressure and, in ventilatory mode. -controlled by volume, we will increase 50% of the tidal volume for a period of 10 minutes, observing the peak that cannot exceed 40 cmH2O in both ventilation modes, and then three aspirations will be performed for 15 seconds and with an interval of 30 seconds.

Study groups in NCT04583371
Study groupRoleWhat they receive
GROUP CONTROLNo interventionFor basal aspiration, the patient will be placed in the supine position with the head elevated at 30º, will be submitted to a single aspiration with a size 12 probe (Mark Med), with a vacuum adjusted to -40cmH2O of pressure, with basic asepsis care being maintained for performing the technique. In the control group, patients will be ventilated for 1 minute with 100% inspired oxygen (FiO2), followed by three aspirations for 15 seconds and with an interval of 30 seconds.
INTERVENTION GROUPActive comparatorFor basal aspiration, the patient will be placed in the supine position with the head elevated at 30º, will be submitted to a single aspiration with a size 12 probe (Mark Med), with a vacuum adjusted to -40cmH2O of pressure, with basic asepsis care being maintained for performing the technique. In the participants of the intervention group, the calculation of the ideal tidal volume of each patient will be performed, after which they will be positioned in the supine position, the headboard elevated to 30º in assisted pressure-controlled ventilatory mode, increasing 10 cmH2O in inspiratory pressure and in assisted ventilation mode. -controlled by volume, we will increase 50% of the tidal volume for a period of 10 minutes, with Ppeak not exceeding 40 cmH2O and drive pressure not exceeding 15 cmH2O in both ventilation modes, and then a new aspiration in the same way as the control group.
Receives: Other: MECHANICAL PULMONARY HYPERINFLUATION

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. amount of secretion

    ml

    Measured: 15 minutes after the technique.

Secondary outcomes (10)
  1. heart rate

    bpm

    Measured: Immediately before and after ande during the technique.

  2. respiratory rate

    bpm

    Measured: Immediately before and after and during the technique.

  3. mean arterial pressure systolic and dyastolic blood pressure

    mmhg

    Measured: Immediately before and after ande during the technique.

  4. peripheral saturation

    SpO2 %

    Measured: Immediately before and after ande during the technique.

  5. static compliance

    ml/cmH2O

    Measured: Immediately before and after ande during the technique.

  6. dynamic compliance

    ml/cmH2O

    Measured: Immediately before and after ande during the technique.

  7. current air volume

    ml

    Measured: Immediately before and after ande during the technique.

  8. peak pressure

    cmH2O

    Measured: Immediately before and after ande during the technique.

  9. plateau pressure

    cmH2O

    Measured: Immediately before and after ande during the technique.

  10. drive pressure

    cmH2O

    Measured: Immediately before and after ande during the technique.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2020
  2. Study start1 Jul 2020
  3. Primary completion30 Jan 2021 (estimated)
  4. Study completion1 Mar 2021 (estimated)

Resources

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
Crossover
Model description
This is a randomized crossover clinical trial in which the individuals selected for the study will be randomized to receive isolated tracheal aspiration (Control Group) and pulmonary hyperinflation through the mechanical ventilator associated with tracheal aspiration (Intervention Group). Randomization will be performed through the randomization.com website by a 1: 1 crossed block, allocating the patient to one of the groups and, after 24 hours, another technique will be performed. In addition, a control aspiration will be performed 2 hours before both techniques.
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04583371
Sponsor's protocol ID
HPMVSASP
Status last verified
Oct 2020
First submitted
29 Sep 2020
Last updated
12 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Carvalho CR, Toufen C Jr, Franca SA. [Mechanical ventilation: principles, graphic analysis and ventilatory modalities]. J Bras Pneumol. 2007;33 Suppl 2S:S54-70. doi: 10.1590/s1806-37132007000800002. No abstract available. Portuguese.

    PubMed 18026665
  • Franca EE, Ferrari F, Fernandes P, Cavalcanti R, Duarte A, Martinez BP, Aquim EE, Damasceno MC. Physical therapy in critically ill adult patients: recommendations from the Brazilian Association of Intensive Care Medicine Department of Physical Therapy. Rev Bras Ter Intensiva. 2012 Mar;24(1):6-22. English, Portuguese.

    PubMed 23917708
  • Dennis DM, Jacob WJ, Samuel FD. A survey of the use of ventilator hyperinflation in Australian tertiary intensive care units. Crit Care Resusc. 2010 Dec;12(4):262-8.

    PubMed 21143087
  • Lemes DA, Zin WA, Guimaraes FS. Hyperinflation using pressure support ventilation improves secretion clearance and respiratory mechanics in ventilated patients with pulmonary infection: a randomised crossover trial. Aust J Physiother. 2009;55(4):249-54. doi: 10.1016/s0004-9514(09)70004-2.

    PubMed 19929767
  • Naue Wda S, Forgiarini Junior LA, Dias AS, Vieira SR. Chest compression with a higher level of pressure support ventilation: effects on secretion removal, hemodynamics, and respiratory mechanics in patients on mechanical ventilation. J Bras Pneumol. 2014 Jan-Feb;40(1):55-60. doi: 10.1590/S1806-37132014000100008.

    PubMed 24626270
  • Favretto DO, Silveira RC, Canini SR, Garbin LM, Martins FT, Dalri MC. Endotracheal suction in intubated critically ill adult patients undergoing mechanical ventilation: a systematic review. Rev Lat Am Enfermagem. 2012 Sep-Oct;20(5):997-1007. doi: 10.1590/s0104-11692012000500023. English, Portuguese, Spanish.

    PubMed 23174846

Questions about this trial

What is this clinical trial studying?

A study testing MECHANICAL PULMONARY HYPERINFLUATION in people with Heart Diseases, run by Instituto de Cardiologia do Rio Grande do Sul 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 3 inclusion and 5 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 12 Oct 2020. 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 Marcela Olixewski, Bacharel (55 51998078004, marcelapolixewski@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

amount of secretion (time frame: 15 minutes after the technique.). 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 NCT04583371, which also lists 6 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 12 Oct 2020.

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