Ignite Creation Date:
2024-05-06 @ 2:29 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02054039
Status:
UNKNOWN
Last Update Posted:
2014-02-25
First Post:
2014-02-01
Brief Title:
Incentive Spirometry and Breath Stacking
Sponsor:
Federal University of São Paulo
Organization:
Federal University of São Paulo
Study Overview
Official Title:
Comparison Between Incentive Spirometry and Breath Stacking After Cardiac Surgery
Status:
UNKNOWN
Status Verified Date:
2014-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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
a1 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
a2 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
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
a1 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
a2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None