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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04583371
Enrollment
50
Registered
2020-10-12
Start date
2020-07-01
Completion date
2021-03-01
Last updated
2020-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Diseases

Keywords

PHYSIOTHERAPY, Mechanical Ventilation

Brief 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 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.

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.

Interventions

OTHERMECHANICAL PULMONARY HYPERINFLUATION

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.

Sponsors

Instituto de Cardiologia do Rio Grande do Sul
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
amount of secretion15 minutes after the technique.ml

Secondary

MeasureTime frameDescription
heart rateImmediately before and after ande during the technique.bpm
respiratory rateImmediately before and after and during the technique.bpm
mean arterial pressure systolic and dyastolic blood pressureImmediately before and after ande during the technique.mmhg
peripheral saturationImmediately before and after ande during the technique.SpO2 %
peak pressureImmediately before and after ande during the technique.cmH2O
dynamic complianceImmediately before and after ande during the technique.ml/cmH2O
current air volumeImmediately before and after ande during the technique.ml
plateau pressureImmediately before and after ande during the technique.cmH2O
drive pressureImmediately before and after ande during the technique.cmH2O
static complianceImmediately before and after ande during the technique.ml/cmH2O

Countries

Brazil

Contacts

Primary ContactMarcela Olixewski, Bacharel
marcelapolixewski@hotmail.com55 51998078004
Backup ContactDaiane Pereira, Bacharel
daiane.silvpereira@gmail.com55 51 999187736

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026