Comparison Between Different Ventilator Hyperinflation Maneuvers

NCT ID: NCT03631342

Last Updated: 2018-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-18

Study Completion Date

2018-05-23

Brief Summary

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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

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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).

Conditions

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Infections, Respiratory Ventilator Associated Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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VCV20

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

Group Type EXPERIMENTAL

VCV20

Intervention Type OTHER

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

VCV40

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

Group Type EXPERIMENTAL

VCV40

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

PCV

Intervention Type 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

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.

Group Type EXPERIMENTAL

PCV+Tins

Intervention Type 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

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.

Group Type EXPERIMENTAL

PSV

Intervention Type 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.

Interventions

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VCV20

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

Intervention Type OTHER

VCV40

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

Intervention Type OTHER

PCV

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

Intervention Type OTHER

PCV+Tins

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.

Intervention Type OTHER

PSV

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brazilian Institute of Higher Education of Censa

OTHER

Sponsor Role lead

Responsible Party

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Luciano Matos Chicayban

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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LUCIANO M CHICAYBAN, MSc

Role: PRINCIPAL_INVESTIGATOR

Brazilian Institute of Higher Education of Censa

Locations

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Luciano M Chicayban

Campos dos Goytacazes, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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VHI Modality

Identifier Type: -

Identifier Source: org_study_id

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