Effects of Inspiratory Flow Waveforms on Preload

November 7, 2016 updated by: Hajjej Zied, Military Hospital of Tunis

Arterial Pulse Pressure Variation and Inferior Vena Cava Distensibility Affected by Inspiratory Flow Waveforms in Mechanically Ventilated Patients: Time for a Change

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
    • Mont Fleury
      • Tunis, Mont Fleury, Tunisia, 1008
        • Military Hospital of Tunis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • mechanical ventilation
  • Volume AssistControl Ventilation
  • sinus rhythm

Exclusion Criteria:

  • pressure mode
  • arrhythmia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: mechanically ventilated patients

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
Device: varying inspiratory flow waveforms
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in pulse pressure variation (ΔPP) and distensibility index of the inferior vena cava (dIVC)when varying inspiratory flow waveforms
Time Frame: 2h
Each inspiratory flow waveform was maintained for 30 min with 60 minutes washout period
2h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Military Hospital of Tunis

Investigators

  • Principal Investigator: zied hajjej, Dr, Military Hospital of Tunis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

June 26, 2013

First Submitted That Met QC Criteria

July 1, 2013

First Posted (ESTIMATE)

July 4, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 9, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CvDVPPIVC
  • CvD1977 (OTHER: Military Hospital of Tunis)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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