Noninvasive Ventilation and Thoracic-abdominal Kinematics in Heart Failure Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Noninvasive ventilation

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50670-901
      • Departamento de Fisioterapia da UFPE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Without performing any operation (Phase Control)
Experimental: With ventilatory support through NIV (NIV Phase)	Other: Noninvasive ventilation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Seven days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Seven days

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco
• Collaborators: Pronto Socorro Cardiológico de Pernambuco-PROCAPE

Publications and helpful links

General Publications

• 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.

Helpful Links

• database on health

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: February 25, 2014
• First Submitted That Met QC Criteria: February 26, 2014
• First Posted (Estimate): February 27, 2014

Study Record Updates

• Last Update Posted (Estimate): February 27, 2014
• Last Update Submitted That Met QC Criteria: February 26, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: DissertaçãoLarissaPOE