Comparison Between Different Ventilator Hyperinflation Maneuvers

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.

Study Overview

• Status: Completed
• Conditions: Ventilator Associated Pneumonia; Infections, Respiratory
• Intervention / Treatment: Other: VCV20; Other: VCV40; Other: PCV; Other: PCV+Tins; Other: PSV

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Campos Dos Goytacazes, RJ, Brazil, 28015150
      • Luciano M Chicayban

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VCV20; Volume-controlled ventilation mode under constant flow of 20 Lpm. The inspired volume was progressively increased until the maximum pressure reached 40cmH2O.	Other: VCV20; controlled volume ventilation mode under constant flow of 20 Lpm. The inspired volume was progressively increased until the Pmax reached 40cmH2O.
Experimental: VCV40; Volume controlled ventilation mode under constant flow of 40 Lpm. The inspired volume was progressively increased until the maximum pressure reached 40cmH2O.	Other: VCV40; volume controlled ventilation mode under constant flow of 40 Lpm. The inspired volume was progressively increased until the Pmax reached 40cmH2O.
Experimental: 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.	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.
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Brazilian Institute of Higher Education of Censa
• Investigators: Principal Investigator: LUCIANO M CHICAYBAN, MSc, Brazilian Institute of Higher Education of Censa

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2017
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): May 23, 2018

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Physical Therapy; Mechanical Ventilation; Ventilator Hyperinflation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Respiratory Tract Infections; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: VHI Modality

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No