Breath and Air Stacking on Respiratory Mechanics in Tracheostomized Patients

July 4, 2019 updated by: Luciano Matos Chicayban, Brazilian Institute of Higher Education of Censa

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

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • RJ
      • Campos Dos Goytacazes, RJ, Brazil, 28015150
        • Luciano M Chicayban

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (before) and immediately after Breath Stacking or Air Stacking
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.
Baseline (before) and immediately after Breath Stacking or Air Stacking

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2018

Primary Completion (Actual)

October 18, 2018

Study Completion (Actual)

May 14, 2019

Study Registration Dates

First Submitted

July 4, 2019

First Submitted That Met QC Criteria

July 4, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 4, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Air and Breath Stacking

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mechanical Ventilation

Clinical Trials on Breath Stacking

3
Subscribe