NCT01525121

Brief Summary

This is a randomized crossover study, designed to evaluate if the manual expiratory rib cage compression technique improves respiratory mechanics and is effective in secretion removal in mechanically ventilated patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

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

July 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
Last Updated

February 2, 2012

Status Verified

February 1, 2012

Enrollment Period

11 months

First QC Date

January 28, 2012

Last Update Submit

February 1, 2012

Conditions

Keywords

mechanical ventilationchest physiotherapycritical carepneumoniaMechanically ventilated patients with pulmonary infection.

Outcome Measures

Primary Outcomes (1)

  • Sputum Volume (mL)

    Day 1

Secondary Outcomes (1)

  • Respiratory Mechanics

    Day 1

Study Arms (2)

Expiratory Rib Cage Compression

EXPERIMENTAL

This a crossover study, so all subjects performed both, control and experimental interventions. The patients were kept in supine at 30 degree head-up position. Ventilatory mode was changed to volume-controlled, with a tidal volume of 8mL/kg, inspiratory flow of 60 Lpm and positive end expiratory pressure (PEEP) of 5 cmH2O. A first tracheal suctioning was done, and the mucus was discarded. Then, a series of two minutes of bilateral expiratory rib-cage compressions ensued. Aiming to minimize inter-therapist variability, the maneuver was applied by the same registered and trained physiotherapist. Control intervention followed the same sequence, but instead of the compressive maneuver they were kept on normal ventilation with the parameters described above.

Other: Expiratory Rib Cage Compression

Control

NO INTERVENTION

This a crossover study, so all subjects performed both, control and experimental interventions. The patients were kept in supine at 30 degree head-up position. Ventilatory mode was changed to volume-controlled, with a tidal volume of 8mL/kg, inspiratory flow of 60 Lpm and positive end expiratory pressure (PEEP) of 5 cmH2O. A first tracheal suctioning was done, and the mucus was discarded. Then, a series of two minutes of bilateral expiratory rib-cage compressions ensued. Aiming to minimize inter-therapist variability, the maneuver was applied by the same registered and trained physiotherapist. Control intervention followed the same sequence, but instead of the compressive maneuver they were kept on normal ventilation with the parameters described above.

Interventions

The therapist hands were positioned on the lower ribs, and the force was applied every two breaths only during the expiration, synchronizing the maneuver rate with the patient's respiratory rate. Then, the patients underwent a suctioning procedure, and a hyperinflation maneuver consisting of a 10 minutes period under pressure support ventilation of 35 cmH2O was done. In control intervention instead of the compressive maneuver the patients were kept on normal ventilation.

Also known as: Manual thoracic compression
Expiratory Rib Cage Compression

Eligibility Criteria

Age19 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 (defined as the interval between tracheal suctioning \< 2 hours)

You may not qualify if:

  • haemodynamic instability (defined by heart rate \> 130 bpm and mean arterial pressure \< 60 mmHg)
  • use of vasopressor drugs
  • absence of respiratory drive
  • acute bronchospasm
  • acute respiratory distress syndrome
  • atelectasis (identified by an independent radiologist that was not participating in the study)
  • untreated pneumothorax
  • lung haemorrhage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Universitário Augusto Motta

Rio de Janeiro, Rio de Janeiro, 21041-010, Brazil

Location

Related Publications (1)

  • Guimaraes FS, Lopes AJ, Constantino SS, Lima JC, Canuto P, de Menezes SL. Expiratory rib cage Compression in mechanically ventilated subjects: a randomized crossover trial [corrected]. Respir Care. 2014 May;59(5):678-85. doi: 10.4187/respcare.02587. Epub 2013 Oct 8.

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Fernando S Guimarães, PhD

    Centro Universitário Augusto Motta

    STUDY CHAIR
  • Sara LS Menezes, PhD

    Centro Universitário Augusto Motta

    PRINCIPAL INVESTIGATOR
  • Agnaldo J Lopes, PhD

    Centro Universitário Augusto Motta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 28, 2012

First Posted

February 2, 2012

Study Start

July 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

February 2, 2012

Record last verified: 2012-02

Locations