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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02073253
Enrollment
24
Registered
2014-02-27
Start date
2013-03-31
Completion date
2013-12-31
Last updated
2014-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

OTHERNoninvasive 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.

Sponsors

Pronto Socorro Cardiológico de Pernambuco-PROCAPE
CollaboratorUNKNOWN
Universidade Federal de Pernambuco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Thoraco-abdominal kinematicsSeven daysThe 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

MeasureTime frameDescription
Other ventilatory responsesSeven daysThe 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026