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Clinical Trials/NCT02073253
NCT02073253
Completed
Not Applicable

Effect of Noninvasive Ventilation in Thoracic-abdominal Kinematics of Individuals With Heart Failure Associated With Cardiomegaly: a Randomized Controlled Trial

Universidade Federal de Pernambuco1 site in 1 country24 target enrollmentMarch 2013
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Universidade Federal de Pernambuco
Enrollment
24
Locations
1
Primary Endpoint
Thoraco-abdominal kinematics
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
December 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniella Cunha Brandao

PhD

Universidade Federal de Pernambuco

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.

Outcomes

Primary Outcomes

Thoraco-abdominal kinematics

Time Frame: Seven days

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 Outcomes

  • Other ventilatory responses(Seven days)

Study Sites (1)

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