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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04012489
Other study ID # Air and Breath Stacking
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 25, 2018
Est. completion date May 14, 2019

Study information

Verified date July 2019
Source Brazilian Institute of Higher Education of Censa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date May 14, 2019
Est. primary completion date October 18, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.
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.

Locations

Country Name City State
Brazil Luciano M Chicayban Campos Dos Goytacazes RJ

Sponsors (1)

Lead Sponsor Collaborator
Brazilian Institute of Higher Education of Censa

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline (before) and immediately after Breath Stacking or Air Stacking
Primary 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. Baseline (before) and immediately after Breath Stacking or Air Stacking
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