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NCT Number: NCT03630510

Ventilator Hyperinflation With Increase of Inspiratory Time

The investigators hypothesis is that the adjustment of the inspiratory time may optimize the distribution of ventilation and increase tidal volume, producing potential therapeutic effects on the displacement of secretions and respiratory mechanics. The objective of this study was To evaluate the effects of hyperinflation with the ventilator associated with increased inspiratory time on respiratory mechanics.

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Key information

Conditions

Lung Infection Mechanical Ventilation

Age range

18 year–80 year

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

A randomized crossover clinical trial was conducted with 38 mechanically ventilated patients with pulmonary infection. The order of hyperinflation or control (without changes in parameters) was randomized. Hyperinflation was performed for 5 minutes in the controlled pressure ventilation mode, with progressive increases of 5cmH2O until reaching a maximum pressure of 35cmH2O, maintaining PEEP. After reaching 35cmH2O, the inspiratory time and respiratory rate were adjusted so that the inspiratory and expiratory flows reached the baseline, respectively. Static compliance (Cest, sr), total resistance (Rsr) and airway resistance (Rva), slow pressure drop (ΔP2) and peak expiratory flow (PEF) were assessed before (PRÉ), immediately after the maneuver (POSSimed) and after aspiration (POSPasp). Two-way ANOVA was used for repeated measurements with Tukey post-test, considering a significant p <0.05.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients under mechanical ventilation for more than 48h
  • Mucus hypersecretion (defined as the need for suctioning < 2-h intervals)

Exclusion criteria

  • Severe bronchospasm,
  • Positive end expiratory pressure > 10cmH2O,
  • PaO2-FiO2 relationship < 150,
  • Mean arterial pressure < 60mmHg,
  • Pleural effusion or pneumothorax undrained,
  • Bronchopleural or tracheoesophageal fistula,
  • Decompensated congestive heart failure.

Treatment and study plan

Ventilator Hyperinflation

Other

The ventilator hyperinflation maneuver with inspiratory time adjustment was performed in the pressure controlled ventilation mode (PCV). The inspiratory pressure was increased gradually every 5 cmH2O until reaching a maximum pressure of 35 cmH2O, according to the tolerance of the patient determined by the absence of cough. PEEP remained unchanged throughout the study. After reaching a maximum pressure of 35 cmH2O (PCV + PEEP level), 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. The maneuver was performed for 5 min, followed by tracheal aspiration.

Primary outcomes

  1. Static compliance of respiratory system

    Time frame: Baseline (before), immediately after VHI and five minutes after aspiration

    Compliance was assessed through the occlusion maneuver at the end of inspiration, considering tidal volume, plateau pressure and PEEP. Three measurements were taken at each moment, the mean being used.

  2. Total Resistance of respiratory system

    Time frame: Baseline (before), immediately after VHI and five minutes after aspiration

    The total resistance of the respiratory system was evaluated through the occlusion maneuver at the end of the inspiration, considering the resistive pressure, measured by the difference between the maximum plateau pressure. Three measurements were taken at each moment, the mean being used.

  3. Airway Resistance

    Time frame: Baseline (before), immediately after VHI and five minutes after aspiration

    The airway resistance was assessed by means of the occlusion maneuver at the end of the inspiration, considering the rapid fall of the pressure immediately after the occlusion, measured by the difference between the maximum pressure and P1. Three measurements were taken at each moment, the mean being used.

  4. Peak expiratory flow

    Time frame: Baseline (before), immediately after VHI and five minutes after aspiration

    The peak expiratory flow was evaluated through passive expiration, being considered the greatest value of the flow in the expiratory phase.

Sponsors and collaborators

Lead sponsor

Brazilian Institute of Higher Education of Censa

Other

Registry information

Official study title

Ventilator Hyperinflation With Increase of Inspiratory Time on Respiratory Mechanics: A Randomized Crossover Trial

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.

View the official ClinicalTrials.gov record (opens in a new tab)

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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