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Ventilator Hyperinflation With Increase of Inspiratory Time

Primary Purpose

Lung Infection, Mechanical Ventilation

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Ventilator hyperinflation
Sponsored by
Brazilian Institute of Higher Education of Censa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Infection focused on measuring Physical Therapy Modalities,, Respiration Artificial,, Respiratory Care Units,, Respiratory Mechanics,, Positive-Pressure Respiration

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients under mechanical ventilation for more than 48h
  • Mucus hypersecretion (defined as the need for suctioning < 2-h intervals)

Exclusion Criteria:

  • Severe bronchospasm,
  • Positive end expiratory pressure > 10cmH2O,
  • PaO2-FiO2 relationship < 150,
  • Mean arterial pressure < 60mmHg,
  • Pleural effusion or pneumothorax undrained,
  • Bronchopleural or tracheoesophageal fistula,
  • Decompensated congestive heart failure.

Sites / Locations

  • Luciano M Chicayban

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

mechanical ventilator hyperinflation

Control

Arm Description

The VHI maneuver with inspiratory time adjustment was performed in the pressure controlled ventilation mode (PCV). The inspiratory pressure was increased gradually every 5 cmH2O until reaching a maximum pressure of 35 cmH2O, according to the tolerance of the patient determined by the absence of cough. PEEP remained unchanged throughout the study. After reaching a maximum pressure of 35 cmH2O (PCV + PEEP level), 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. The maneuver was performed for 5 min, followed by tracheal aspiration.

To perform the control (CTRL), the patients were only positioned and aspirated, without alteration in ventilatory parameters.

Outcomes

Primary Outcome Measures

Static compliance of respiratory system
Compliance was assessed through the occlusion maneuver at the end of inspiration, considering tidal volume, plateau pressure and PEEP. Three measurements were taken at each moment, the mean being used.
Total Resistance of respiratory system
The total resistance of the respiratory system was evaluated through the occlusion maneuver at the end of the inspiration, considering the resistive pressure, measured by the difference between the maximum plateau pressure. Three measurements were taken at each moment, the mean being used.
Airway Resistance
The airway resistance was assessed by means of the occlusion maneuver at the end of the inspiration, considering the rapid fall of the pressure immediately after the occlusion, measured by the difference between the maximum pressure and P1. Three measurements were taken at each moment, the mean being used.
Peak expiratory flow
The peak expiratory flow was evaluated through passive expiration, being considered the greatest value of the flow in the expiratory phase.

Secondary Outcome Measures

Full Information

First Posted
March 2, 2017
Last Updated
August 9, 2018
Sponsor
Brazilian Institute of Higher Education of Censa
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1. Study Identification

Unique Protocol Identification Number
NCT03630510
Brief Title
Ventilator Hyperinflation With Increase of Inspiratory Time
Official Title
Ventilator Hyperinflation With Increase of Inspiratory Time on Respiratory Mechanics: A Randomized Crossover Trial
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
August 12, 2017 (Actual)
Study Completion Date
March 28, 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 investigators hypothesis is that the adjustment of the inspiratory time may optimize the distribution of ventilation and increase tidal volume, producing potential therapeutic effects on the displacement of secretions and respiratory mechanics. The objective of this study was To evaluate the effects of hyperinflation with the ventilator associated with increased inspiratory time on respiratory mechanics.
Detailed Description
A randomized crossover clinical trial was conducted with 38 mechanically ventilated patients with pulmonary infection. The order of hyperinflation or control (without changes in parameters) was randomized. Hyperinflation was performed for 5 minutes in the controlled pressure ventilation mode, with progressive increases of 5cmH2O until reaching a maximum pressure of 35cmH2O, maintaining PEEP. After reaching 35cmH2O, the inspiratory time and respiratory rate were adjusted so that the inspiratory and expiratory flows reached the baseline, respectively. Static compliance (Cest, sr), total resistance (Rsr) and airway resistance (Rva), slow pressure drop (ΔP2) and peak expiratory flow (PEF) were assessed before (PRÉ), immediately after the maneuver (POSSimed) and after aspiration (POSPasp). Two-way ANOVA was used for repeated measurements with Tukey post-test, considering a significant p <0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Infection, Mechanical Ventilation
Keywords
Physical Therapy Modalities,, Respiration Artificial,, Respiratory Care Units,, Respiratory Mechanics,, Positive-Pressure Respiration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The VHI maneuver with inspiratory time adjustment was performed in the pressure controlled ventilation mode (PCV). The inspiratory pressure was increased gradually every 5 cmH2O until reaching a maximum pressure of 35 cmH2O, according to the tolerance of the patient determined by the absence of cough. PEEP remained unchanged throughout the study. The maneuver was performed for 5 min, followed by tracheal aspiration. To perform the control (CTRL), the patients were only positioned and aspirated, without alteration in ventilatory parameters.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mechanical ventilator hyperinflation
Arm Type
Experimental
Arm Description
The VHI maneuver with inspiratory time adjustment was performed in the pressure controlled ventilation mode (PCV). The inspiratory pressure was increased gradually every 5 cmH2O until reaching a maximum pressure of 35 cmH2O, according to the tolerance of the patient determined by the absence of cough. PEEP remained unchanged throughout the study. After reaching a maximum pressure of 35 cmH2O (PCV + PEEP level), 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. The maneuver was performed for 5 min, followed by tracheal aspiration.
Arm Title
Control
Arm Type
No Intervention
Arm Description
To perform the control (CTRL), the patients were only positioned and aspirated, without alteration in ventilatory parameters.
Intervention Type
Other
Intervention Name(s)
Ventilator hyperinflation
Intervention Description
The ventilator hyperinflation maneuver with inspiratory time adjustment was performed in the pressure controlled ventilation mode (PCV). The inspiratory pressure was increased gradually every 5 cmH2O until reaching a maximum pressure of 35 cmH2O, according to the tolerance of the patient determined by the absence of cough. PEEP remained unchanged throughout the study. After reaching a maximum pressure of 35 cmH2O (PCV + PEEP level), 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. The maneuver was performed for 5 min, followed by tracheal aspiration.
Primary Outcome Measure Information:
Title
Static compliance of respiratory system
Description
Compliance was assessed through the occlusion maneuver at the end of inspiration, considering tidal volume, plateau pressure and PEEP. Three measurements were taken at each moment, the mean being used.
Time Frame
Baseline (before), immediately after VHI and five minutes after aspiration
Title
Total Resistance of respiratory system
Description
The total resistance of the respiratory system was evaluated through the occlusion maneuver at the end of the inspiration, considering the resistive pressure, measured by the difference between the maximum plateau pressure. Three measurements were taken at each moment, the mean being used.
Time Frame
Baseline (before), immediately after VHI and five minutes after aspiration
Title
Airway Resistance
Description
The airway resistance was assessed by means of the occlusion maneuver at the end of the inspiration, considering the rapid fall of the pressure immediately after the occlusion, measured by the difference between the maximum pressure and P1. Three measurements were taken at each moment, the mean being used.
Time Frame
Baseline (before), immediately after VHI and five minutes after aspiration
Title
Peak expiratory flow
Description
The peak expiratory flow was evaluated through passive expiration, being considered the greatest value of the flow in the expiratory phase.
Time Frame
Baseline (before), immediately after VHI and five minutes after aspiration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients under mechanical ventilation for more than 48h Mucus hypersecretion (defined as the need for suctioning < 2-h intervals) Exclusion Criteria: Severe bronchospasm, Positive end expiratory pressure > 10cmH2O, PaO2-FiO2 relationship < 150, Mean arterial pressure < 60mmHg, Pleural effusion or pneumothorax undrained, Bronchopleural or tracheoesophageal fistula, Decompensated congestive heart failure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LUCIANO M CHICAYBAN
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
Citations:
PubMed Identifier
31618346
Citation
Chicayban LM. Acute effects of ventilator hyperinflation with increased inspiratory time on respiratory mechanics: randomized crossover clinical trial. Rev Bras Ter Intensiva. 2019 Oct 14;31(3):289-295. doi: 10.5935/0103-507X.20190052. eCollection 2019.
Results Reference
derived

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Ventilator Hyperinflation With Increase of Inspiratory Time

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