Incentive Spirometry and Breath Stacking

NCT02054039 | Unknown Phase 1 DMC

• 1 other identifier: 186.780
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

\- 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
• 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 .
• 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.

Conditions

Postoperative Complications

Keywords

Cardiac surgery; Spirometry; Physical Therapy Modalities; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Pulmonary complications

  * Pneumonia * Atelectasis * Acute respiratory infection

  18 months

Secondary Outcomes (2)

• Lung Function

  18 months

• Respiratory muscle strength

  18 months

Other Outcomes (2)

• hospital stay

  18 months

• Mortality from pulmonary cause

  18 months

Study Arms (2)

Incentive spirometry (IS)

EXPERIMENTAL

Group I

Device: Incentive spirometry (IS)

Breath stacking (BS)

ACTIVE COMPARATOR

Group II

Device: Breath Stacking (BS)

Interventions

Incentive spirometry (IS) DEVICE

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.

Incentive spirometry (IS)

Breath Stacking (BS) DEVICE

Equipment with a one-way valve that masks and promotes the accumulation of successive inspiratory volumes, preventing expiration

Breath stacking (BS)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Hospital Santa Casa de Londrina

Londrina, Paraná, 86020060, Brazil

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eliane Freitas, PhD

  Federal University of São Paulo and University of Northern Parana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliane Freitas, PhD

CONTACT

55+ 43 99951354; elianefe@sercomtel.com.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Eliane Regina Ferreira Sernache de Freitas

Study Record Dates

• First Submitted: February 1, 2014
• First Posted: February 4, 2014
• Study Start: February 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

BR (1)