Effects of Inspiratory Flow Waveforms on Preload
Primary Purpose
Cardiac Output, Low
Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
varying inspiratory flow waveforms
Sponsored by
About this trial
This is an interventional supportive care trial for Cardiac Output, Low focused on measuring inspiratory flow pattern, mechanical ventilation, cardiac preload, arterial pulse pressure variation, inferior vena cava collapsibility
Eligibility Criteria
Inclusion Criteria:
- mechanical ventilation
- Volume AssistControl Ventilation
- sinus rhythm
Exclusion Criteria:
- pressure mode
- arrhythmia
Sites / Locations
- Military hospital of tunis
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
mechanically ventilated patients
Arm Description
patients admitted to a 18-bed medical surgical intensive care unit of the military hospital of Tunisia and were mechanically ventilated fully adapted to their ventilator and in sinus rhythm. intervention:varying inspiratory flow waveforms
Outcomes
Primary Outcome Measures
change in pulse pressure variation (ΔPP) and distensibility index of the inferior vena cava (dIVC)when varying inspiratory flow waveforms
Each inspiratory flow waveform was maintained for 30 min with 60 minutes washout period
Secondary Outcome Measures
Full Information
NCT ID
NCT01892696
First Posted
June 26, 2013
Last Updated
November 7, 2016
Sponsor
Military Hospital of Tunis
1. Study Identification
Unique Protocol Identification Number
NCT01892696
Brief Title
Effects of Inspiratory Flow Waveforms on Preload
Official Title
Arterial Pulse Pressure Variation and Inferior Vena Cava Distensibility Affected by Inspiratory Flow Waveforms in Mechanically Ventilated Patients: Time for a Change
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Military Hospital of Tunis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The clinical usefulness of inspiratory flow pattern manipulation during mechanical ventilation remains unclear. The aim of this study was to investigate the effects of different inspiratory flow waveforms, i.e. constant and decelerating, on cardiac preload in mechanically ventilated patients assessed by arterial pulse pressure variation (PPV) and inferior vena cava distensibility.
Detailed Description
During mechanical ventilation the lungs can be inflated with different pressure and flow waveforms. Originally the piston-driven mechanical ventilators generated a quasi-sinusoidal flow waveform, whereas the newer electronically controlled ventilators can also produce constant and decelerating waveforms. According to several theoretical,animal and clinical studies,the inspiratory flow waveform affects the distribution of the inspired gas as well as respiratory mechanics and gas exchange. However, other studies failed to show any significant effect.But there is no study interested to the effects of inspiratory flow waveforms on cardiac preload. Thus, the clinical usefulness of inspiratory flow pattern manipulation remains unclear, though the capacity for selection of different inspiratory flow waveforms is provided by most modern, microprocessor-equipped ventilators. Therefore, the purpose of this study was to compare the effects of flow patterns (sinusoidal, constant and decelerating) on dynamic measurements of cardiac preload dependence such as arterial pulse pressure variation (ΔPP) and distensibility index of the inferior vena cava (dIVC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Output, Low
Keywords
inspiratory flow pattern, mechanical ventilation, cardiac preload, arterial pulse pressure variation, inferior vena cava collapsibility
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mechanically ventilated patients
Arm Type
Other
Arm Description
patients admitted to a 18-bed medical surgical intensive care unit of the military hospital of Tunisia and were mechanically ventilated fully adapted to their ventilator and in sinus rhythm.
intervention:varying inspiratory flow waveforms
Intervention Type
Device
Intervention Name(s)
varying inspiratory flow waveforms
Intervention Description
inspiratory flow waveform was changed, in a randomized sequence using a computer ,to one of the following modalities: 1) constant inspiratory flow; 2) decelerating inspiratory flow Each inspiratory flow waveform was maintained for 30 min. During the last 5 min of this period the physiological signals were collected and measures were performed.
Primary Outcome Measure Information:
Title
change in pulse pressure variation (ΔPP) and distensibility index of the inferior vena cava (dIVC)when varying inspiratory flow waveforms
Description
Each inspiratory flow waveform was maintained for 30 min with 60 minutes washout period
Time Frame
2h
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mechanical ventilation
Volume AssistControl Ventilation
sinus rhythm
Exclusion Criteria:
pressure mode
arrhythmia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zied hajjej, Dr
Organizational Affiliation
Military Hospital of Tunis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Military hospital of tunis
City
Tunis
State/Province
Mont Fleury
ZIP/Postal Code
1008
Country
Tunisia
12. IPD Sharing Statement
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Effects of Inspiratory Flow Waveforms on Preload
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