Breath and Air Stacking on Respiratory Mechanics in Tracheostomized Patients

Sponsor

Brazilian Institute of Higher Education of Censa (Other)

Overall Status

Completed

CT.gov ID

NCT04012489

Collaborator

(none)

Enrollment

Location

Arms

14.6

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Mechanical Ventilation Lung Infection	Procedure: Breath Stacking Procedure: Air Stacking	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 25, 2018

Actual Primary Completion Date :

Oct 18, 2018

Actual Study Completion Date :

May 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.
Experimental: 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.	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.

Arm

Intervention/Treatment

Active Comparator: 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.

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.

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

Static compliance of respiratory system [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.
Total Resistance of respiratory system [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Luciano M Chicayban	Campos Dos Goytacazes	RJ	Brazil	28015150

Sponsors and Collaborators

Brazilian Institute of Higher Education of Censa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luciano Matos Chicayban, Laboratório de Pesquisa em Fisioterapia Pneumofuncional e Intensiva (LAPEFIPI), Brazilian Institute of Higher Education of Censa

ClinicalTrials.gov Identifier:

NCT04012489

Other Study ID Numbers:

Air and Breath Stacking

First Posted:

Jul 9, 2019

Last Update Posted:

Jul 9, 2019

Last Verified:

Jul 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Luciano Matos Chicayban, Laboratório de Pesquisa em Fisioterapia Pneumofuncional e Intensiva (LAPEFIPI), Brazilian Institute of Higher Education of Censa

Physical Therapy Modalities

Respiratory Care Units

Respiratory Mechanics

Study Results

No Results Posted as of Jul 9, 2019