Ventilator Hyperinflation and Manual Rib Cage Compression

Sponsor

Brazilian Institute of Higher Education of Censa (Other)

Overall Status

Completed

CT.gov ID

NCT03630484

Collaborator

(none)

Enrollment

Arms

31.4

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Atelectasis	Other: Expiratory Rib Cage Compression Other: Compression + Ventilator Hyperinflation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 28, 2014

Actual Primary Completion Date :

Dec 5, 2014

Actual Study Completion Date :

Jul 11, 2017

Arms and Interventions

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.	Other: Expiratory Rib Cage Compression 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.	Other: Compression + Ventilator Hyperinflation 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.

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.

Other: Expiratory Rib Cage Compression

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.

Other: Compression + Ventilator Hyperinflation

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.

Outcome Measures

Primary Outcome Measures

Static compliance of respiratory system [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.
Total Resistance of respiratory system [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.
Airway Resistance [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.
Peak expiratory flow [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Brazilian Institute of Higher Education of Censa

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luciano Matos Chicayban, Principal Investigator, Brazilian Institute of Higher Education of Censa

ClinicalTrials.gov Identifier:

NCT03630484

Other Study ID Numbers:

VHI + Rib Cage Compression

First Posted:

Aug 15, 2018

Last Update Posted:

Aug 15, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

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

Keywords provided by Luciano Matos Chicayban, Principal Investigator, Brazilian Institute of Higher Education of Censa

Ventilator Hyperinflation

Expiratory Rib Cage Compression

Physical Therapy

Mechanical Ventilation

Additional relevant MeSH terms:

Pulmonary Atelectasis

Study Results

No Results Posted as of Aug 15, 2018