NCT02073253

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

Same day

First QC Date

February 25, 2014

Last Update Submit

February 26, 2014

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Other ventilatory responses

    Seven days

Study Arms (2)

Without performing any operation (Phase Control)

NO INTERVENTION

With ventilatory support through NIV (NIV Phase)

EXPERIMENTAL
Other: Noninvasive ventilation

Interventions

Noninvasive ventilationOTHER

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.

With ventilatory support through NIV (NIV Phase)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departamento de Fisioterapia da UFPE

Recife, Pernambuco, 50670-901, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 20952768RESULT

Related Links

MeSH Terms

Conditions

Heart Failure

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 25, 2014

First Posted

February 27, 2014

Study Start

March 1, 2013

Primary Completion

March 1, 2013

Study Completion

December 1, 2013

Last Updated

February 27, 2014

Record last verified: 2014-02

Locations

BR(1)