Ventilator Hyperinflation With Increase of Inspiratory Time

Not Applicable

Completed

• Conditions: Mechanical Ventilation; Lung Infection

• Registration Number: NCT03630510
• Lead Sponsor: Brazilian Institute of Higher Education of Censa

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-03-02
• Study Start: 2017-03-18
• Primary Completion: 2017-08-12
• Study Completion: 2018-03-28
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-09
• Last Update Submitted: 2018-08-09
• Study First Posted: 2018-08-15
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Static compliance of respiratory system	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.
Total Resistance of respiratory system	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.
Airway Resistance	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.
Peak expiratory flow	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.

Trial Locations

Locations (1)

Luciano M Chicayban; 🇧🇷 Campos Dos Goytacazes, RJ, Brazil