- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04012489
Breath and Air Stacking on Respiratory Mechanics in Tracheostomized Patients
July 4, 2019 updated by: Luciano Matos Chicayban, Brazilian Institute of Higher Education of Censa
Comparison Between Breath Stacking and Air Stacking on Respiratory Mechanics and Ventilatory Pattern in Tracheostomized Patients: Randomized Crossover Trial
The researchers hypothesized that the aid of the resuscitator by the technique Air Stacking increase lung volume, promoting increased lung compliance and improvement of the ventilatory pattern.
In addition, Air Stacking does not depend on patient collaboration.
The objective of this study was to compare the effects of breath stacking and air stacking techniques on respiratory mechanics and ventilatory pattern in patients admitted to the ICU
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RJ
-
Campos Dos Goytacazes, RJ, Brazil, 28015150
- Luciano M Chicayban
-
-
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
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients without mechanical ventilation for more than 72 hours
- Mucus hypersecretion (defined as the need for suctioning < 2-h intervals)
Exclusion Criteria:
- bronchospasm.
- Pleural effusion or pneumothorax undrained.
- Bronchopleural or tracheoesophageal fistula.
- Neuromuscular disease.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Breath Stacking
Breath stacking: patients were connected to a unidirectional valve coupled to artificial airway (tracheostomy), with bacteriological filter.
The ventilator was coupled to the unidirectional valve to measure inspiratory volume mobilized in each cycle and a connection to adapt a manometer.
The patient performed successive inspirations for a maximum period of 30 seconds or until unidirectional valve opening or volume increase was observed for 2 consecutive efforts.
Ten cycles of the technique were performed, with an interval of 30 seconds.
|
Patients were connected to a unidirectional valve coupled to artificial airway (tracheostomy), with bacteriological filter.
The ventilator was coupled to the unidirectional valve to measure inspiratory volume mobilized in each cycle and a connection to adapt a manometer.
The patient performed successive inspirations for a maximum period of 30 seconds or until unidirectional valve opening or volume increase was observed for 2 consecutive efforts.
Ten cycles of the technique were performed, with an interval of 30 seconds.
|
Experimental: Air Stacking
Air stacking: the same system of monitoring and adaptation of the ventilometer and manometer was carried out.
A manual resuscitator coupled to a unidirectional valve was used, both connected to the tracheostomy, with a filter interface.
Slow and successive inspirations were performed through slow compression of the resuscitator until the maximum inspiratory pressure reached 40 cmH2O.
Ten cycles of the technique were performed, with an interval of 30 seconds.
|
The same system of monitoring and adaptation of the ventilometer and manometer was carried out.
A manual resuscitator coupled to a unidirectional valve was used, both connected to the tracheostomy, with a filter interface.
Slow and successive inspirations were performed through slow compression of the resuscitator until the maximum inspiratory pressure reached 40 cmH2O.
Ten cycles of the technique were performed, with an interval of 30 seconds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Static compliance of respiratory system
Time Frame: Baseline (before) and immediately after Breath Stacking or Air Stacking
|
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) and immediately after Breath Stacking or Air Stacking
|
Total Resistance of respiratory system
Time Frame: Baseline (before) and immediately after Breath Stacking or Air Stacking
|
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) and immediately after Breath Stacking or Air Stacking
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
February 25, 2018
Primary Completion (Actual)
October 18, 2018
Study Completion (Actual)
May 14, 2019
Study Registration Dates
First Submitted
July 4, 2019
First Submitted That Met QC Criteria
July 4, 2019
First Posted (Actual)
July 9, 2019
Study Record Updates
Last Update Posted (Actual)
July 9, 2019
Last Update Submitted That Met QC Criteria
July 4, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- Air and Breath Stacking
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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