Incentive Spirometry and Breath Stacking

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Federal University of São Paulo
Sponsor:
Information provided by (Responsible Party):
Eliane Regina Ferreira Sernache de Freitas, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT02054039
First received: February 1, 2014
Last updated: February 23, 2014
Last verified: February 2014
  Purpose

- Postoperative pulmonary complications in patients undergoing cardiac surgery are a major clinical problem, presenting negative impact on morbidity, mortality , length of hospital stay and health care costs. Although physical therapy has been widely used as a resource to improve lung function in the postoperative period, the adoption of routine procedures of physical therapy needs be discussed.

  • Incentive spirometers are mechanical devices used to reduce postoperative pulmonary complications. In general, they are activated by an inspiratory effort, visualized by an uplifted plate or ball in a transparent cylinder during sustained inspiration.
  • Breath Stacking is a technique allowing the patient inhale a greater volume of air, kept for a longer period of time using a one-way valve, thus promoting the accumulation of successive inspiratory volume and preventing exhalation.
  • The objective of the study is to evaluate the effectiveness of two different techniques of respiratory therapy on both reducing postoperative pulmonary complications and improving lung function.
  • Type of study : randomized clinical trial
  • Hypothesis

    1. Both techniques Trifllo II Incentive Spirometry ( IS) (Trifllo ® - II ) and Breath Stacking ( BS ) may present similar effectiveness on reducing pulmonary complications, improving lung function and respiratory muscle strength ( MIP and MEP), as well as reducing hospital stay .
    2. Trifllo II Incentive Spirometry ( IS) (Trifllo ® - II ) may be more effective than Breath Stacking on reducing pulmonary complications, improving lung function and respiratory muscle strength, as well as reducing hospital stay.

Condition Intervention Phase
Postoperative Complications
Device: Incentive spirometry (IS)
Device: Breath Stacking (BS)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison Between Incentive Spirometry and Breath Stacking After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Pulmonary complications [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    • Pneumonia
    • Atelectasis
    • Acute respiratory infection


Secondary Outcome Measures:
  • Lung Function [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Lung function will be assessed by spirometry, aimed at measuring the forced vital capacity (FVC), forced expiratory volume in one second (VFE1), and the ratio CVF/VFE1

  • Respiratory muscle strength [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Respiratory muscle strength will be assessed by measuring both the maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). The values obtained for each volunteer on the respective predicted values for the Brazilian population, according to the prediction equations proposed by Neder et al will be compared.


Other Outcome Measures:
  • hospital stay [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Length of hospital stay in days, in the immediate postoperative period ( POI ) with the arrival of the patient in the ICU until discharge or death .

  • Mortality from pulmonary cause [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Mortality from pulmonary causes will be derived from primary and secondary causes, and will be considered a medical inference.


Estimated Enrollment: 118
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Incentive spirometry (IS)
Group I
Device: Incentive spirometry (IS)
Mechanical devices activated by an inspiratory effort, which is viewed by the elevation of a plateau or balls in a transparent cylinder having a calibrated scale that displays the inspired flow.
Active Comparator: Breath stacking (BS)
Group II
Device: Breath Stacking (BS)
Equipment with a one-way valve that masks and promotes the accumulation of successive inspiratory volumes, preventing expiration

Detailed Description:
  • Type of study : randomized clinical trial
  • Study site: The study will be carried out at the Hospital Santa Casa de Londrina.
  • Subjects: all patients scheduled for cardiac surgery will be studied ( CABG and / or valve replacement )
  • Patients will be evaluated both preoperatively, and on the fifth postoperative day (POD). They will be informed about the procedures to which they will be submitted, as well as the objective of the proposed study preoperatively. If approved by the patient, the "Statement of Informed Consent - SIC" will be signed.
  • Inclusion Criteria

    a. Individuals admitted to the Hospital Santa Casa de Londrina (HSCL) with programming for cardiac surgery with cardiopulmonary bypass, age above 18 years; and referral for surgery by the study teams. Individuals must be aware, informed, and agreed to participate in the study, including signing of SIC.

  • Exclusion Criteria a. Individuals with cognitive impairment that prevents the implementation of spirometry (lung function ), manovacuometry (MIP and MEP) and incentive spirometry, below 18 years of age, patients with chronic obstructive pulmonary disease diagnosed by clinical history and spirometry ( FVC < 80 % predicted and / or FEV1 < 70 % predicted ) and individuals with a history of asthma.

b . Patients will be withdrawn from the study and the Intention to Treat Analysis will be performed in the case of: patients who cannot be extubated because of the need for continuing mechanical ventilation after 24 hours of post-operative complications in the postoperative period; hemodynamic instability ; myocardial infarction during operation ; severe blood loss defined by the medical staff; loss of 20 % or more of total blood volume ( 12 ); mean arterial pressure (MAP ) < 70 mmHg,; reduced cardiac output requiring the use of intra-aortic balloon or vasoactive drugs for more than 72 hours, after ICU admission or need for new reintubation. Patients who did not agree to participate by not signing the SIC.

  • Procedures and interventions a. randomization

    a.1 . After being selected by the inclusion criteria and had signed the informed consent preoperatively, patients will be allocated to one of two groups based on Consort ;

    a.2 . The allocation will be generated through a standardized random table. The allocation concealment will be ensured using opaque envelopes, sealed, and numbered serially. The envelope containing a card with the treatment will be opened by a secretary responsible for that.

  • Formation of groups a. EI Group I - Intervention with flow-oriented incentive spirometry (IS) ( Trifllo ® - II ).

b . BS Group II - Intervention with Breath- Stacking technique (BS).

  • Recording and evaluation of the patient: patients included in the study will be recorded and evaluated by a physical therapist involved in the trial (blind) according to the standardized forms.
  • Duration of the intervention: Both therapy modalities (Group I and Group II) will be held twice daily during the ICU stay, and once a day during hospitalization in the ward, until the fifth postoperative day. Each session will consist of three sets of five maneuvers.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Subjects admitted to the Hospital Santa Casa de Londrina (HSCL) with programming for cardiac surgery with cardiopulmonary bypass, age above 18 years, and referral for surgery by the study teams. Individuals must be aware, informed, and agreed to participate in the study, including signing of SIC

Exclusion Criteria:

  • Individuals with cognitive impairment that prevents the implementation of spirometry (lung function ), manovacuometry (MIP and MEP) and incentive spirometry; below 18 years of age; patients with chronic obstructive pulmonary disease diagnosed by clinical history and spirometry ( FVC < 80 % of predicted and / or FEV1 < 70 % predicted); and individuals with a history of asthma.
  • Patients will be withdrawn from the study and the Intention to Treat Analysis will be performed in the case of: patients who cannot be extubated because of the need for continuing mechanical ventilation after 24 hours of post-operative complications in the postoperative period; hemodynamic instability ; myocardial infarction during operation ; severe blood loss defined by the medical staff; loss of 20 % or more of total blood volume; mean arterial pressure (MAP ) < 70 mmHg; reduced cardiac output requiring the use of intra-aortic balloon or vasoactive drugs for more than 72 hours, after ICU admission or need for new reintubation. Patients who did not agree to participate by not signing the SIC
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02054039

Contacts
Contact: Eliane Freitas, PhD 55+ 43 99951354 elianefe@sercomtel.com.br

Locations
Brazil
Hospital Santa Casa de Londrina Recruiting
Londrina, Paraná, Brazil, 86020060
Contact: Eliane FS Freitas, PhD    55+4399951354    elianefe@sercomtel.com.br   
Principal Investigator: Eliane FS Freitas, PhD         
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Eliane Freitas, PhD Federal University of São Paulo and University of Northern Parana
  More Information

No publications provided

Responsible Party: Eliane Regina Ferreira Sernache de Freitas, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02054039     History of Changes
Other Study ID Numbers: 186.780
Study First Received: February 1, 2014
Last Updated: February 23, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Cardiac surgery
Spirometry
Physical Therapy Modalities
Postoperative Complications

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014