Ventilator Hyperinflation and Manual Rib Cage Compression

August 9, 2018 updated by: Luciano Matos Chicayban, Brazilian Institute of Higher Education of Censa

Comparison Between Ventilator Hyperinflation and Manual Rib Cage Compression: Randomized Crossover Trial

This is a randomized crossover trial to evaluate the effects of thoracic compression applied alone or in association with hyperinflation maneuver with the ventilator. In addition, the mobilized volume and peak expiratory flow resulting from both maneuvers will be evaluated.

Study Overview

Detailed Description

Ventilator hyperinflation is widely used in hypersecretive patients. It consists of increasing alveolar ventilation by facilitating the coughing mechanism so that the secretions of the peripheral airways are mobilized into the central airways so that they can be removed by tracheal aspiration or cough. Thoracic compression consists of manually compressing the rib cage during expiration, in order to increase expiratory flow, mobilize and remove pulmonary secretions. A randomized crossover clinical trial was performed with 30 patients submitted to isolated compression or associated with ventilator hyperinflation, with a 6 hour interval. Patients were evaluated through compliance and resistance of the respiratory system.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients under mechanical ventilation
  • diagnosis of pulmonary infection
  • hypersecretive

Exclusion Criteria:

  • haemodynamic instability (heart rate > 130 bpm and mean arterial pressure < 60 mmHg)
  • acute bronchospasm
  • acute respiratory distress syndrome
  • untreated pneumothorax

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Expiratory Rib Cage Compression
Expiratory rib cage compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilatory mode and parameters were maintained.
Compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilatory mode and parameters were maintained.
Active Comparator: Compression + Ventilator Hyperinflation
Expiratory rib cage compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilator hyperinflation was performed by increasing the inspiratory pressure to every 5 cmH2O until the total pressure reached 40 cmH2O, remaining the same.
Mechanical ventilator hyperinflation was performed by increasing the inspiratory pressure to every 5 cmH2O until the total pressure reached 40 cmH2O, remaining the same. In Expiratory Rib Cage Compression associated with ventilator hyperinflation, thoracic compression maneuver was performed at the end of inspiration, at the exact moment of cycling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Static compliance of respiratory system
Time Frame: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
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), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
Total Resistance of respiratory system
Time Frame: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
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), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
Airway Resistance
Time Frame: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
The airway resistance was assessed by means of the occlusion maneuver at the end of the inspiration, considering the rapid fall of the pressure immediately after the occlusion, measured by the difference between the maximum pressure and P1. Three measurements were taken at each moment, the mean being used.
Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
Peak expiratory flow
Time Frame: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
The peak expiratory flow was evaluated through passive expiration, being considered the greatest value of the flow in the expiratory phase.
Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration

Collaborators and Investigators

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

Investigators

  • Principal Investigator: LUCIANO M CHICAYBAN, MSc, Brazilian Institute of Higher Education of Censa

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)

November 28, 2014

Primary Completion (Actual)

December 5, 2014

Study Completion (Actual)

July 11, 2017

Study Registration Dates

First Submitted

August 6, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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