Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01416519
Other study ID # U1111-1123-6476
Secondary ID 0035/2010
Status Completed
Phase N/A
First received August 12, 2011
Last updated November 17, 2014
Start date September 2011
Est. completion date January 2014

Study information

Verified date November 2014
Source Santa Casa de Votuporanga
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

Coronary artery bypass graft (CABG) can prolong and improve the quality of life of patients with ischemic coronary syndrome but with the advancement of medical intervention to eligible patients for this procedure are those with more comorbidities where conservation and palliative therapies have been tried without success.

Patients undergoing CABG often develop pulmonary complications such as atelectasis, restrictive ventilatory defect, decreased lung compliance, increased shunt and changes in gas exchange leading to probable hypoxemia. In an attempt to reduce the harmful effects and pulmonary complications arising from surgical procedures is instituted extensive physiotherapy program that tracks and monitors such patients from the preoperative to the postoperative immediate transfer to the ward and hospital discharge.

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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Procedure:
Continuous Positive Airway Pressure (CPAP) facial mask
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.
Assisted deep inspiration technique
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.

Locations

Country Name City State
Brazil Santa Casa Votuporanga Votuporanga São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Santa Casa de Votuporanga

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pulmonary complications Occurrence of pulmonary complications such as pneumonia, atelectasis or pleural effusion diagnosed with chest X-rays by ICU doctor. 72 hours Yes
Secondary Exams Assessment of (Sat O2) capillary saturation, (ABG) arterial blood gases. 72 hours Yes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04244474 - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children Phase 1/Phase 2
Completed NCT05815264 - Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above Phase 1
Recruiting NCT04589936 - Prone Position to Improve Oxygenation in COVID-19 Patients Outside Critical Care N/A
Completed NCT02905383 - The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital N/A
Completed NCT06210737 - A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months,7 Months-5 Years Phase 4
Terminated NCT03944551 - Bubble Continuous Positive Airway Pressure for Children With Severe Pneumonia in Mali, Africa N/A
Terminated NCT04660084 - Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT05702788 - Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19) Phase 2
Not yet recruiting NCT04171674 - Pharmacokinetics of High-dose Ceftobiprole in Community-acquired Pneumonia Under Mechanical Ventilation. N/A
Active, not recruiting NCT03140163 - Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR] N/A
Completed NCT02864420 - Hospitalization at Home: The Acute Care Home Hospital Program for Adults N/A
Completed NCT02638649 - Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
Recruiting NCT02515565 - Physiotherapy in Patients Hospitalized Due to Pneumonia. N/A
Completed NCT02105298 - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study) N/A
Completed NCT01399723 - Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia Phase 3
Completed NCT01446926 - Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants Phase 1
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT01416506 - Community-Acquired Pneumonia (CAP) Surveillance N/A
Terminated NCT02358642 - Drug to Prevent Pneumonia in the Tube Fed Phase 4