Clinical trial NCT03631342: Comparison Between Different Ventilator Hyperinflation Maneuvers
Official title: Comparison Between Different Ventilator Hyperinflation Maneuvers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infections, Respiratory
Ventilator Associated Pneumonia
Keywords: Ventilator Hyperinflation
Physical Therapy
Mechanical Ventilation
Lead sponsor: Brazilian Institute of Higher Education of Censa
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In order to perform both interventions, the patients were placed in dorsal decubitus with a head elevated at 45 ° and submitted to closed tracheal aspiration, according to the recommendations of the American Association for Respiratory Care. In addition, the bacteriological filter was changed, the cuff pressure was increased and the presence of leaks in the mechanical fan circuits was verified.

All patients underwent five hyperinflation maneuvers, the order being determined by randomization. Controlled volume ventilation (VCV) at a constant flow rate of 20 Lpm (VCV-20) and 40 Lpm (VCV-40), controlled pressure ventilation (VCV-40) was performed for 2 minutes at 10 minute intervals. PCV), pressure-controlled ventilation associated with inspiratory time adjustment (PCV + Tins) and pressure-supported ventilation (PSV). PEEP and FiO2 were maintained throughout the study.
Primary purpose: OTHER

Brief summary: The hyperinflation ventilator was performed in different modalities and ventilatory adjustments, with total pressure of 40cmH2O. The inspiratory volume, inspiratory time, mean airway pressure, inspiratory and expiratory flow, and bias flow were evaluated.

Detailed description: PURPOSE: To compare different ways of applying ventilator hyperinflation. METHODS: A randomized crossover clinical trial was performed with 30 patients (66.5 ± 17.3 years) with hypersecretion. The ventilator hyperinflation was performed in five ventilatory modalities for five minutes, with an interval of 2 hours, the order being determined by randomization: controlled ventilation at volume (VCV) with constant flow of 20 (VCV20) Lpm and 40 Lpm (VCV40), controlled ventilation pressure ventilation (PCV), controlled pressure ventilation associated with inspiratory time adjustment (PCV + Tins) and support pressure ventilation (PSV). In VCV mode, the volume was increased every 50mL, until reaching a maximum pressure of 40cmH2O. In the pressure controlled modes, the inspiratory pressure was increased every 5 cmH2O until the total pressure reached 40 cmH2O. The inspiratory time was adjusted so that the inspiratory flow reached the baseline. The following variables were evaluated: tidal volume, inspiratory time (Tins), mean airway pressure (Pmean), peak inspiratory flow (PIFR) and expiratory flow (PEFR), PIFR / PEFR and Bias Flow (PEFR-PIFR).

Eligibility criteria: Inclusion Criteria:

* Pulmonary infection
* Mechanically ventilated for more than 96 hours through pressure-assisted ventilation (PSV) or pressure-controlled ventilation (PCV)
* Static compliance between 30 and 70 mL/cmH2O
* PEEP between 5 and 8 cmH2O.

Exclusion Criteria:

* Hemodynamic instability
* Non-drained pleural effusion or pneumothorax
* Intracranial hypertension
* Bronchospasm
* Adult respiratory distress syndrome (ARDS)
* Decompensated congestive heart failure

Primary outcomes:
measure: Inspiratory Volume
timeFrame: Five minutes after the onset of intervention
measure: Inspiratory time
timeFrame: Five minutes after the onset of intervention
measure: Mean Pressure
timeFrame: Five minutes after the onset of intervention
measure: Peak Expiratory Flow
timeFrame: Five minutes after the onset of intervention
measure: Peak Inspiratory Flow
timeFrame: Five minutes after the onset of intervention
measure: PIFR/PEFR
timeFrame: Five minutes after the onset of intervention
measure: Bias Flow
timeFrame: Five minutes after the onset of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Campos Dos Goytacazes
country: Brazil
facility: Luciano M Chicayban
state: RJ
Study officials:
affiliation: Brazilian Institute of Higher Education of Censa
name: LUCIANO M CHICAYBAN, MSc
role: PRINCIPAL_INVESTIGATOR
References: