NCT01416519

Brief Summary

The objective of this study is to assess whether there is a difference between a care protocol with the use of incentive spirometry (Voldyne ®) and another with the application of NIV (non invasive ventilation with single-level pressure) as a form of therapy. The main focus of the study is to determine the incidence of pulmonary complications in each technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

August 12, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2011

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

2.3 years

First QC Date

August 12, 2011

Last Update Submit

November 17, 2014

Conditions

PneumoniaPleural EffusionAtelectasis

Keywords

Continuous Positive Airway PressureCoughOxygen Inhalation Therapy

Outcome Measures

Primary Outcomes (1)

  • Pulmonary complications

    Occurrence of pulmonary complications such as pneumonia, atelectasis or pleural effusion diagnosed with chest X-rays by ICU doctor.

    72 hours

Secondary Outcomes (1)

  • Exams

    72 hours

Study Arms (2)

Group 1

EXPERIMENTAL

After extubation, starting non-invasive ventilation with face mask (1 hour) followed by assisted cough maneuver. Total of 18 calls in 72 hours distributed as long the patient was extubated.

Procedure: Continuous Positive Airway Pressure (CPAP) facial mask

Group 2

EXPERIMENTAL

After extubation, starting early supplemental oxygen with Venturi (FiO2 50%) with gradual weaning, applying assisted deep inspiration technique with Voldyne(R) with four sets of 10 repetitions and assisted cough maneuver. Total of 18 calls in 72 hours distributed as long the patient was extubated.

Procedure: Assisted deep inspiration technique

Interventions

Continuous Positive Airway Pressure (CPAP) facial maskPROCEDURE

After extubation, starting non-invasive ventilation with face mask (1 hour) followed by assisted cough maneuver. Total of 18 calls in 72 hours distributed as long the patient was extubated.

Also known as: CPAP
Group 1
Assisted deep inspiration techniquePROCEDURE

After extubation, starting early supplemental oxygen with Venturi (FiO2 50%) with gradual weaning, applying assisted deep inspiration technique with Voldyne(R) with four sets of 10 repetitions and assisted cough maneuver. Total of 18 calls in 72 hours distributed as long the patient was extubated.

Also known as: Voldyne
Group 2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with indication for elective coronary artery bypass surgery who agreed to participate and signed the informed consent.

You may not qualify if:

  • patients with hemodynamic instability during the physiotherapy care
  • those who fail to complete all visits to the proposed protocol (whatever the reason)
  • extubation after 12 hours of ICU admission
  • major intraoperative hemorrhage
  • major bleeding in ICU requiring return to the operating room
  • cardiopulmonary arrest
  • contraindication to positive pressure (undrained pneumothorax, bronchopleural fistula, hemoptysis, vomiting) or intolerance to the method

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Casa Votuporanga

Votuporanga, São Paulo, 15500-003, Brazil

Location

MeSH Terms

Conditions

PneumoniaPleural EffusionPulmonary AtelectasisCough

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesPleural DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Marcos Aurelio Barboza de Oliveira, MD

    Santa Casa Votuporanga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

August 12, 2011

First Posted

August 15, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

BR(1)