Breath and Air Stacking on Respiratory Mechanics in Tracheostomized Patients

Mechanical Ventilation Clinical Trial

Official title:

Comparison Between Breath Stacking and Air Stacking on Respiratory Mechanics and Ventilatory Pattern in Tracheostomized Patients: Randomized Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04012489
• Other study ID #: Air and Breath Stacking
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Lung Infection
• Mechanical Ventilation

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