Comparison Between Different Ventilator Hyperinflation Maneuvers

Not Applicable

Completed

• Conditions: Infections, Respiratory; Ventilator Associated Pneumonia
• Interventions: Other: VCV20; Other: VCV40; Other: PCV; Other: PCV+Tins; Other: PSV

• Registration Number: NCT03631342
• Lead Sponsor: Brazilian Institute of Higher Education of Censa

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).

Study Timeline

• Study Start: 2017-03-18
• Primary Completion: 2017-09-30
• Study Completion: 2018-05-23
• Status Verified: 2018-08
• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-13
• Last Update Submitted: 2018-08-13
• Study First Posted: 2018-08-15
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
VCV20	VCV20	Volume-controlled ventilation mode under constant flow of 20 Lpm. The inspired volume was progressively increased until the maximum pressure reached 40cmH2O.
VCV40	VCV40	Volume controlled ventilation mode under constant flow of 40 Lpm. The inspired volume was progressively increased until the maximum pressure reached 40cmH2O.
PCV	PCV	Pressure controlled ventilation mode, inspiratory time of 1 second. The inspiratory pressure was increased every 5 cmH2O, until reaching the maximum pressure of 40 cmH2O.
PCV+Tins	PCV+Tins	Pressure controlled ventilation mode and inspiratory pressure was increased every 5cmH2O, until the maximum pressure of 40 cmH2O was reached. 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	PSV	Pressure support ventilation mode, 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 Outcome Measures

Name	Time	Method
Peak Expiratory Flow	Five minutes after the onset of intervention	maximal expiratory flow in 2 cycles
PIFR/PEFR	Five minutes after the onset of intervention	Peak inspiratory to expiratory flow ratio
Bias Flow	Five minutes after the onset of intervention	Difference between peak inspiratory and expiratory flows
Inspiratory Volume	Five minutes after the onset of intervention	Inspiratory volume reached in each mode of ventilator hyperinflation, under a maximum pressure of 40cmH2O
Mean Pressure	Five minutes after the onset of intervention	airway mean pressure measured on the mechanical ventilator in 2 cycles
Peak Inspiratory Flow	Five minutes after the onset of intervention	Maximal inspiratory flow in 2 cycles
Inspiratory time	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

Trial Locations

Locations (1)

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