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Comparison Between Different Ventilator Hyperinflation Maneuvers

Primary Purpose

Infections, Respiratory, Ventilator Associated Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
VCV20
VCV40
PCV
PCV+Tins
PSV
Sponsored by
Brazilian Institute of Higher Education of Censa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infections, Respiratory focused on measuring Ventilator Hyperinflation, Physical Therapy, Mechanical Ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Luciano M Chicayban

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

VCV20

VCV40

PCV

PCV+Tins

PSV

Arm Description

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

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

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.

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.

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.

Outcomes

Primary Outcome Measures

Inspiratory Volume
Inspiratory volume reached in each mode of ventilator hyperinflation, under a maximum pressure of 40cmH2O
Inspiratory time
inspiratory time necessary for the inspiratory flow to reach the baseline or according to the settings of each modality
Mean Pressure
airway mean pressure measured on the mechanical ventilator in 2 cycles
Peak Expiratory Flow
maximal expiratory flow in 2 cycles
Peak Inspiratory Flow
Maximal inspiratory flow in 2 cycles
PIFR/PEFR
Peak inspiratory to expiratory flow ratio
Bias Flow
Difference between peak inspiratory and expiratory flows

Secondary Outcome Measures

Full Information

First Posted
August 6, 2018
Last Updated
August 13, 2018
Sponsor
Brazilian Institute of Higher Education of Censa
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1. Study Identification

Unique Protocol Identification Number
NCT03631342
Brief Title
Comparison Between Different Ventilator Hyperinflation Maneuvers
Official Title
Comparison Between Different Ventilator Hyperinflation Maneuvers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 18, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
May 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brazilian Institute of Higher Education of Censa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Respiratory, Ventilator Associated Pneumonia
Keywords
Ventilator Hyperinflation, Physical Therapy, Mechanical Ventilation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VCV20
Arm Type
Experimental
Arm Description
Volume-controlled ventilation mode under constant flow of 20 Lpm. The inspired volume was progressively increased until the maximum pressure reached 40cmH2O.
Arm Title
VCV40
Arm Type
Experimental
Arm Description
Volume controlled ventilation mode under constant flow of 40 Lpm. The inspired volume was progressively increased until the maximum pressure reached 40cmH2O.
Arm Title
PCV
Arm Type
Experimental
Arm Description
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.
Arm Title
PCV+Tins
Arm Type
Experimental
Arm Description
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.
Arm Title
PSV
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
VCV20
Intervention Description
controlled volume ventilation mode under constant flow of 20 Lpm. The inspired volume was progressively increased until the Pmax reached 40cmH2O.
Intervention Type
Other
Intervention Name(s)
VCV40
Intervention Description
volume controlled ventilation mode under constant flow of 40 Lpm. The inspired volume was progressively increased until the Pmax reached 40cmH2O.
Intervention Type
Other
Intervention Name(s)
PCV
Intervention Description
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
Intervention Name(s)
PCV+Tins
Intervention Description
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
Intervention Name(s)
PSV
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inspiratory Volume
Description
Inspiratory volume reached in each mode of ventilator hyperinflation, under a maximum pressure of 40cmH2O
Time Frame
Five minutes after the onset of intervention
Title
Inspiratory time
Description
inspiratory time necessary for the inspiratory flow to reach the baseline or according to the settings of each modality
Time Frame
Five minutes after the onset of intervention
Title
Mean Pressure
Description
airway mean pressure measured on the mechanical ventilator in 2 cycles
Time Frame
Five minutes after the onset of intervention
Title
Peak Expiratory Flow
Description
maximal expiratory flow in 2 cycles
Time Frame
Five minutes after the onset of intervention
Title
Peak Inspiratory Flow
Description
Maximal inspiratory flow in 2 cycles
Time Frame
Five minutes after the onset of intervention
Title
PIFR/PEFR
Description
Peak inspiratory to expiratory flow ratio
Time Frame
Five minutes after the onset of intervention
Title
Bias Flow
Description
Difference between peak inspiratory and expiratory flows
Time Frame
Five minutes after the onset of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LUCIANO M CHICAYBAN, MSc
Organizational Affiliation
Brazilian Institute of Higher Education of Censa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luciano M Chicayban
City
Campos Dos Goytacazes
State/Province
RJ
ZIP/Postal Code
28015150
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison Between Different Ventilator Hyperinflation Maneuvers

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