Breath and Air Stacking on Respiratory Mechanics in Tracheostomized Patients

NCT04012489 | Completed DMC

• 1 other identifier: Air and Breath Stacking
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Mechanical Ventilation; Lung Infection

Keywords

Physical Therapy Modalities; Respiratory Care Units; Respiratory Mechanics

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Breath Stacking

ACTIVE COMPARATOR

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.

Procedure: Breath Stacking

Air Stacking

EXPERIMENTAL

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.

Procedure: Air Stacking

Interventions

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.

Breath Stacking

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.

Air Stacking

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients without mechanical ventilation for more than 72 hours
• Mucus hypersecretion (defined as the need for suctioning \< 2-h intervals)

You may not qualify if:

• bronchospasm.
• Pleural effusion or pneumothorax undrained.
• Bronchopleural or tracheoesophageal fistula.
• Neuromuscular disease.

Sponsors & Collaborators

• Brazilian Institute of Higher Education of Censa: lead

Study Sites (1)

Luciano M Chicayban

Campos dos Goytacazes, Rio de Janeiro, 28015150, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Laboratório de Pesquisa em Fisioterapia Pneumofuncional e Intensiva (LAPEFIPI)

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 9, 2019
• Study Start: February 25, 2018
• Primary Completion: October 18, 2018
• Study Completion: May 14, 2019
• Last Updated: July 9, 2019

Record last verified: 2019-07

Locations

BR (1)