Comparison Between Different Ventilator Hyperinflation Maneuvers

NCT03631342 | Completed DMC

• 1 other identifier: VHI Modality
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections, Respiratory; Ventilator Associated Pneumonia

Keywords

Ventilator Hyperinflation; Physical Therapy; Mechanical Ventilation

Outcome Measures

Primary Outcomes (7)

• Inspiratory Volume

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

  Five minutes after the onset of intervention

• Inspiratory time

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

  Five minutes after the onset of intervention

• Mean Pressure

  airway mean pressure measured on the mechanical ventilator in 2 cycles

  Five minutes after the onset of intervention

• Peak Expiratory Flow

  maximal expiratory flow in 2 cycles

  Five minutes after the onset of intervention

• Peak Inspiratory Flow

  Maximal inspiratory flow in 2 cycles

  Five minutes after the onset of intervention

• PIFR/PEFR

  Peak inspiratory to expiratory flow ratio

  Five minutes after the onset of intervention

• Bias Flow

  Difference between peak inspiratory and expiratory flows

  Five minutes after the onset of intervention

Study Arms (5)

VCV20

EXPERIMENTAL

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

Other: VCV20

VCV40

EXPERIMENTAL

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

Other: VCV40

PCV

EXPERIMENTAL

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.

Other: PCV

PCV+Tins

EXPERIMENTAL

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.

Other: PCV+Tins

PSV

EXPERIMENTAL

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.

Other: PSV

Interventions

VCV20 OTHER

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

VCV20

VCV40 OTHER

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

VCV40

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

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.

PCV+Tins

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.

PSV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Hemodynamic instability
• Non-drained pleural effusion or pneumothorax
• Intracranial hypertension
• Bronchospasm
• Adult respiratory distress syndrome (ARDS)
• Decompensated congestive heart failure

Sponsors & Collaborators

• Brazilian Institute of Higher Education of Censa: lead

Study Sites (1)

Luciano M Chicayban

Campos dos Goytacazes, Rio de Janeiro, 28015150, Brazil

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

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

Study Officials

• LUCIANO M CHICAYBAN, MSc

  Brazilian Institute of Higher Education of Censa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 15, 2018
• Study Start: March 18, 2017
• Primary Completion: September 30, 2017
• Study Completion: May 23, 2018
• Last Updated: August 15, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)