Ventilator Hyperinflation and Manual Rib Cage Compression
Primary Purpose
Pulmonary Atelectasis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Expiratory Rib Cage Compression
Compression + Ventilator Hyperinflation
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Atelectasis focused on measuring Ventilator Hyperinflation, Expiratory Rib Cage Compression, Physical Therapy, Mechanical Ventilation
Eligibility Criteria
Inclusion Criteria:
- patients under mechanical ventilation
- diagnosis of pulmonary infection
- hypersecretive
Exclusion Criteria:
- haemodynamic instability (heart rate > 130 bpm and mean arterial pressure < 60 mmHg)
- acute bronchospasm
- acute respiratory distress syndrome
- untreated pneumothorax
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Expiratory Rib Cage Compression
Compression + Ventilator Hyperinflation
Arm Description
Expiratory rib cage compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilatory mode and parameters were maintained.
Expiratory rib cage compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilator hyperinflation was performed by increasing the inspiratory pressure to every 5 cmH2O until the total pressure reached 40 cmH2O, remaining the same.
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
NCT ID
NCT03630484
First Posted
August 6, 2018
Last Updated
August 9, 2018
Sponsor
Brazilian Institute of Higher Education of Censa
1. Study Identification
Unique Protocol Identification Number
NCT03630484
Brief Title
Ventilator Hyperinflation and Manual Rib Cage Compression
Official Title
Comparison Between Ventilator Hyperinflation and Manual Rib Cage Compression: Randomized Crossover Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 28, 2014 (Actual)
Primary Completion Date
December 5, 2014 (Actual)
Study Completion Date
July 11, 2017 (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
No
5. Study Description
Brief Summary
This is a randomized crossover trial to evaluate the effects of thoracic compression applied alone or in association with hyperinflation maneuver with the ventilator. In addition, the mobilized volume and peak expiratory flow resulting from both maneuvers will be evaluated.
Detailed Description
Ventilator hyperinflation is widely used in hypersecretive patients. It consists of increasing alveolar ventilation by facilitating the coughing mechanism so that the secretions of the peripheral airways are mobilized into the central airways so that they can be removed by tracheal aspiration or cough. Thoracic compression consists of manually compressing the rib cage during expiration, in order to increase expiratory flow, mobilize and remove pulmonary secretions. A randomized crossover clinical trial was performed with 30 patients submitted to isolated compression or associated with ventilator hyperinflation, with a 6 hour interval. Patients were evaluated through compliance and resistance of the respiratory system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atelectasis
Keywords
Ventilator Hyperinflation, Expiratory Rib Cage Compression, Physical Therapy, Mechanical Ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Expiratory Rib Cage Compression
Arm Type
Active Comparator
Arm Description
Expiratory rib cage compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilatory mode and parameters were maintained.
Arm Title
Compression + Ventilator Hyperinflation
Arm Type
Active Comparator
Arm Description
Expiratory rib cage compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilator hyperinflation was performed by increasing the inspiratory pressure to every 5 cmH2O until the total pressure reached 40 cmH2O, remaining the same.
Intervention Type
Other
Intervention Name(s)
Expiratory Rib Cage Compression
Intervention Description
Compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilatory mode and parameters were maintained.
Intervention Type
Other
Intervention Name(s)
Compression + Ventilator Hyperinflation
Intervention Description
Mechanical ventilator hyperinflation was performed by increasing the inspiratory pressure to every 5 cmH2O until the total pressure reached 40 cmH2O, remaining the same. In Expiratory Rib Cage Compression associated with ventilator hyperinflation, thoracic compression maneuver was performed at the end of inspiration, at the exact moment of cycling.
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 ventilator hyperinflation or rib cage compression 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 ventilator hyperinflation or rib cage compression 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 ventilator hyperinflation or rib cage compression 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 ventilator hyperinflation or rib cage compression and five minutes after aspiration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients under mechanical ventilation
diagnosis of pulmonary infection
hypersecretive
Exclusion Criteria:
haemodynamic instability (heart rate > 130 bpm and mean arterial pressure < 60 mmHg)
acute bronchospasm
acute respiratory distress syndrome
untreated pneumothorax
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ventilator Hyperinflation and Manual Rib Cage Compression
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