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Completed

NCT Number: NCT03631342

Comparison Between Different Ventilator Hyperinflation Maneuvers

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.

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Key information

Conditions

Infections, Respiratory Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections Ventilator Associated Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Luciano M Chicayban

Campos dos Goytacazes, Rio de Janeiro, 28015150, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VCV20

Other

controlled volume ventilation mode under constant flow of 20 Lpm. The inspired volume was progressively increased until the Pmax reached 40cmH2O.

VCV40

Other

volume controlled ventilation mode under constant flow of 40 Lpm. The inspired volume was progressively increased until the Pmax reached 40cmH2O.

PCV

Other

controlled ventilation mode, 1 second inspiratory time. The inspiratory pressure was increased every 5 cmH2O, until reaching the maximum pressure of 40 cmH2O.

PCV+Tins

Other

controlled ventilation and inspiratory pressure was increased every 5 cmH2O until the maximum pressure was 40 cmH2O. The inspiratory time was gradually increased until the inspiratory flow reached the baseline. Concomitantly, the respiratory rate was decreased to allow the expiratory flow also to reach the baseline, to avoid self-PEEP.

PSV

Other

ventilatory mode with pressure support, with progressive increases of 5 cmH2O at inspiratory pressure, until reaching Pmax of 40 cmH2O. The expiratory sensitivity was adjusted by 25% for all patients.

Primary outcomes

  1. Inspiratory Volume

    Time frame: Five minutes after the onset of intervention

    Inspiratory volume reached in each mode of ventilator hyperinflation, under a maximum pressure of 40cmH2O

  2. Inspiratory time

    Time frame: Five minutes after the onset of intervention

    inspiratory time necessary for the inspiratory flow to reach the baseline or according to the settings of each modality

  3. Mean Pressure

    Time frame: Five minutes after the onset of intervention

    airway mean pressure measured on the mechanical ventilator in 2 cycles

  4. Peak Expiratory Flow

    Time frame: Five minutes after the onset of intervention

    maximal expiratory flow in 2 cycles

  5. Peak Inspiratory Flow

    Time frame: Five minutes after the onset of intervention

    Maximal inspiratory flow in 2 cycles

  6. PIFR/PEFR

    Time frame: Five minutes after the onset of intervention

    Peak inspiratory to expiratory flow ratio

  7. Bias Flow

    Time frame: Five minutes after the onset of intervention

    Difference between peak inspiratory and expiratory flows

Sponsors and collaborators

Lead sponsor

Brazilian Institute of Higher Education of Censa

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 15, 2018
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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