NCT03630484

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2014

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2014

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

7 days

First QC Date

August 6, 2018

Last Update Submit

August 9, 2018

Conditions

Keywords

Ventilator HyperinflationExpiratory Rib Cage CompressionPhysical TherapyMechanical Ventilation

Outcome Measures

Primary Outcomes (4)

  • Static compliance of respiratory system

    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

    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

    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

    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

Study Arms (2)

Expiratory Rib Cage Compression

ACTIVE COMPARATOR

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 + Ventilator Hyperinflation

ACTIVE COMPARATOR

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

Interventions

Compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilatory mode and parameters were maintained.

Expiratory Rib Cage Compression

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.

Compression + Ventilator Hyperinflation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • LUCIANO M CHICAYBAN, MSc

    Brazilian Institute of Higher Education of Censa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 15, 2018

Study Start

November 28, 2014

Primary Completion

December 5, 2014

Study Completion

July 11, 2017

Last Updated

August 15, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share