Breath and Air Stacking on Respiratory Mechanics in Tracheostomized Patients

NCT ID: NCT04012489

Last Updated: 2019-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-25
• Study Completion Date: 2019-05-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Breath Stacking

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Air Stacking

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brazilian Institute of Higher Education of Censa

OTHER

Sponsor Role: lead

Responsible Party

Luciano Matos Chicayban

Laboratório de Pesquisa em Fisioterapia Pneumofuncional e Intensiva (LAPEFIPI)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Luciano M Chicayban

Campos dos Goytacazes, Rio de Janeiro, Brazil

Countries

Brazil

Other Identifiers

Air and Breath Stacking

Identifier Type: -

Identifier Source: org_study_id