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NCT Number: NCT04012489

Breath and Air Stacking on Respiratory Mechanics in Tracheostomized Patients

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

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Key information

Conditions

Mechanical Ventilation Lung Infection

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Luciano M Chicayban

Campos dos Goytacazes, Rio de Janeiro, 28015150, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breath Stacking

Procedure

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

Procedure

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Brazilian Institute of Higher Education of Censa

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jul 9, 2019
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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