- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03630484
Ventilator Hyperinflation and Manual Rib Cage Compression
August 9, 2018 updated by: Luciano Matos Chicayban, Brazilian Institute of Higher Education of Censa
Comparison Between Ventilator Hyperinflation and Manual Rib Cage Compression: Randomized Crossover Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Expiratory Rib Cage Compression
Expiratory rib cage compression was performed in 6 sets of 6 cycles, with 1 cycle interval.
Ventilatory mode and parameters were maintained.
|
Compression was performed in 6 sets of 6 cycles, with 1 cycle interval.
Ventilatory mode and parameters were maintained.
|
Active Comparator: Compression + Ventilator Hyperinflation
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Static compliance of respiratory system
Time Frame: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
|
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.
|
Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
|
Total Resistance of respiratory system
Time Frame: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
|
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.
|
Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
|
Airway Resistance
Time Frame: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
|
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.
|
Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
|
Peak expiratory flow
Time Frame: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
|
The peak expiratory flow was evaluated through passive expiration, being considered the greatest value of the flow in the expiratory phase.
|
Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: LUCIANO M CHICAYBAN, MSc, Brazilian Institute of Higher Education of Censa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 28, 2014
Primary Completion (Actual)
December 5, 2014
Study Completion (Actual)
July 11, 2017
Study Registration Dates
First Submitted
August 6, 2018
First Submitted That Met QC Criteria
August 9, 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 9, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VHI + Rib Cage Compression
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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