Noninvasive Ventilation and Thoracic-abdominal Kinematics in Heart Failure Patients

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Noninvasive ventilation

• Registration Number: NCT02073253
• Lead Sponsor: Universidade Federal de Pernambuco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-12
• Status Verified: 2014-02
• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-02-26
• Last Update Submitted: 2014-02-26
• Study First Posted: 2014-02-27
• Last Update Posted: 2014-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
With ventilatory support through NIV (NIV Phase)	Noninvasive ventilation	-

Primary Outcome Measures

Name	Time	Method
Thoraco-abdominal kinematics	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 Outcome Measures

Name	Time	Method
Other ventilatory responses	Seven days	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.

Trial Locations

Locations (1)

Departamento de Fisioterapia da UFPE; 🇧🇷 Recife, Pernambuco, Brazil