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

NCT04583371 | Unknown DMC

• 1 other identifier: HPMVSASP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Diseases

Keywords

PHYSIOTHERAPY; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• amount of secretion

  ml

  15 minutes after the technique.

Secondary Outcomes (10)

• heart rate

  Immediately before and after ande during the technique.

• respiratory rate

  Immediately before and after and during the technique.

• mean arterial pressure systolic and dyastolic blood pressure

  Immediately before and after ande during the technique.

• peripheral saturation

  Immediately before and after ande during the technique.

• static compliance

  Immediately before and after ande during the technique.

Study Arms (2)

GROUP CONTROL

NO INTERVENTION

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 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 GROUP

ACTIVE COMPARATOR

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 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.

Other: MECHANICAL PULMONARY HYPERINFLUATION

Interventions

MECHANICAL PULMONARY HYPERINFLUATION OTHER

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.

INTERVENTION GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (1)

Instituto de Cardiologia

Porto Alegre, Rio Grande do Sul, 90040371, Brazil

RECRUITING

Related Publications (6)

• 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.

  PMID: 18026665 RESULT

• 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.

  PMID: 23917708 RESULT

• 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.

  PMID: 21143087 RESULT

• 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.

  PMID: 19929767 RESULT

• 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.

  PMID: 24626270 RESULT

• 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.

  PMID: 23174846 RESULT

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Bruna Eibel, Dr

  Instituto de Cardiologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcela Olixewski, Bacharel

CONTACT

55 51998078004; marcelapolixewski@hotmail.com

Daiane Pereira, Bacharel

CONTACT

55 51 999187736; daiane.silvpereira@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 12, 2020
• Study Start: July 1, 2020
• Primary Completion: January 30, 2021
• Study Completion: March 1, 2021
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)