Back to resultsNoninvasive Ventilation and Thoracic-abdominal Kinematics in Heart Failure Patients
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Noninvasive ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- body mass index (BMI) <30 kg/m2
- functional class II-III according to the New York Heart Association
- of the echocardiogram últiimos 6 months showing ejection fraction (LVEF) ≤ 45%,
- últiimos echocardiogram of six months showing cardiac hypertrophy (left Ventricular Diastolic Diameter (LVDD)> 55mm, Diameter Systolic left Ventricular (LVSD)> 45mm ),
- (optimized from the point of view of drug,
- clinical stability.
Exclusion Criteria:
- unstable angina, myocardial infarction or heart surgery three months before the beginning of the research,
- chronic orthopedic, infectious or metabolic diseases,
- FEV1/FVC <70% predicted characterizing obstructive respiratory disorder;
- active smokers;
- Limitation on the use of NIV: claustrophobia, inability to remain with their mouths closed, abdominal distention, hemodynamic instability, heart rate (HR) <60 bpm, recent trauma, nausea and vomiting face.
Sites / Locations
- Departamento de Fisioterapia da UFPE
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Without performing any operation (Phase Control)
With ventilatory support through NIV (NIV Phase)
Arm Description
Outcomes
Primary Outcome Measures
Thoraco-abdominal kinematics
The thoraco-abdominal kinematics was performed by optoelectronic plethysmography which were evaluated as primary outcomes: volume change of rib cage (Δv CT), variables related to volume change of rib cage by hemithorax (ΔV ht CT): tidal volume of cash left thoracic (CT VC sx) and tidal volume right ribcage (VC CT dx); variables with distribution volume in different compartments: tidal volume on pulmonary rib cage (VC CTP), tidal volume in abdominal rib cage (VC CTA ) and tidal volume in the abdomen (AB VC).
Secondary Outcome Measures
Other ventilatory responses
The other ventilatory responses were also assessed by optoelectronic plethysmography which were assessed as secondary outcomes: minute ventilation (MV); Inhalant rate (RR), duty cycle (Ti / Ttot), expiratory time (TE), end of rib cage (VEF CT) expiratory volume.
Full Information
NCT ID
NCT02073253
First Posted
February 25, 2014
Last Updated
February 26, 2014
Sponsor
Universidade Federal de Pernambuco
Collaborators
Pronto Socorro Cardiológico de Pernambuco-PROCAPE
1. Study Identification
Unique Protocol Identification Number
NCT02073253
Brief Title
Noninvasive Ventilation and Thoracic-abdominal Kinematics in Heart Failure Patients
Official Title
Effect of Noninvasive Ventilation in Thoracic-abdominal Kinematics of Individuals With Heart Failure Associated With Cardiomegaly: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco
Collaborators
Pronto Socorro Cardiológico de Pernambuco-PROCAPE
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Introduction: Noninvasive ventilation (NIV) has been used to minimize such impairment and increasing ventilator reserve in individuals with heart failure. Aim: To analyze thoracoabdominal kinematics (TK) in individuals with HF associated to cardiomegaly after using NIV. Methods: A randomized crossover clinical trial with allocation consisted of two experimental phases: NIV and control, 7 days apart of each other. During NIV phase, 30 minutes of bi-level ventilation was performed. Any type of ventilator support was offered during control phase. Optoeletronic plethismography was performed to asses TK.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Without performing any operation (Phase Control)
Arm Type
No Intervention
Arm Title
With ventilatory support through NIV (NIV Phase)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Noninvasive ventilation
Intervention Description
In the experimental phase with NIV ventilatory support with bilevel positive pressure was used for 30 minutes with the subject comfortably seated. The NIV (Vivo 40 Bi-Level, General Electric Company) was fitted to the face of volunteer through a face mask, was initially adopted an inspiratory pressure (IPAP) of 15 cm H2O and an expiratory pressure (PEEP) of 5 cmH2O, resulting in a variation in pressure of 10 cm H2O, where the IPAP would be increased, subject to the comfort of the patient until the patient reached a tidal volume of 6-8 ml / kg, not exceeding the maximum of 20 cmH2O for IPAP.
Primary Outcome Measure Information:
Title
Thoraco-abdominal kinematics
Description
The thoraco-abdominal kinematics was performed by optoelectronic plethysmography which were evaluated as primary outcomes: volume change of rib cage (Δv CT), variables related to volume change of rib cage by hemithorax (ΔV ht CT): tidal volume of cash left thoracic (CT VC sx) and tidal volume right ribcage (VC CT dx); variables with distribution volume in different compartments: tidal volume on pulmonary rib cage (VC CTP), tidal volume in abdominal rib cage (VC CTA ) and tidal volume in the abdomen (AB VC).
Time Frame
Seven days
Secondary Outcome Measure Information:
Title
Other ventilatory responses
Description
The other ventilatory responses were also assessed by optoelectronic plethysmography which were assessed as secondary outcomes: minute ventilation (MV); Inhalant rate (RR), duty cycle (Ti / Ttot), expiratory time (TE), end of rib cage (VEF CT) expiratory volume.
Time Frame
Seven days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
body mass index (BMI) <30 kg/m2
functional class II-III according to the New York Heart Association
of the echocardiogram últiimos 6 months showing ejection fraction (LVEF) ≤ 45%,
últiimos echocardiogram of six months showing cardiac hypertrophy (left Ventricular Diastolic Diameter (LVDD)> 55mm, Diameter Systolic left Ventricular (LVSD)> 45mm ),
(optimized from the point of view of drug,
clinical stability.
Exclusion Criteria:
unstable angina, myocardial infarction or heart surgery three months before the beginning of the research,
chronic orthopedic, infectious or metabolic diseases,
FEV1/FVC <70% predicted characterizing obstructive respiratory disorder;
active smokers;
Limitation on the use of NIV: claustrophobia, inability to remain with their mouths closed, abdominal distention, hemodynamic instability, heart rate (HR) <60 bpm, recent trauma, nausea and vomiting face.
Facility Information:
Facility Name
Departamento de Fisioterapia da UFPE
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50670-901
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
20952768
Citation
Olson TP, Johnson BD. Influence of cardiomegaly on disordered breathing during exercise in chronic heart failure. Eur J Heart Fail. 2011 Mar;13(3):311-8. doi: 10.1093/eurjhf/hfq177. Epub 2010 Oct 16.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/
Description
database on health
Learn more about this trial
Noninvasive Ventilation and Thoracic-abdominal Kinematics in Heart Failure Patients
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