NCT01892696

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2013

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

2 months

First QC Date

June 26, 2013

Last Update Submit

November 7, 2016

Conditions

Cardiac Output, Low

Keywords

inspiratory flow patternmechanical ventilationcardiac preloadarterial pulse pressure variationinferior vena cava collapsibility

Outcome Measures

Primary Outcomes (1)

  • 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

    2h

Study Arms (1)

mechanically ventilated patients

OTHER

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

Interventions

varying inspiratory flow waveformsDEVICE

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.

mechanically ventilated patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • mechanical ventilation
  • Volume AssistControl Ventilation
  • sinus rhythm

You may not qualify if:

  • pressure mode
  • arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military hospital of tunis

Tunis, Mont Fleury, 1008, Tunisia

Location

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • zied hajjej, Dr

    Military Hospital of Tunis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 26, 2013

First Posted

July 4, 2013

Study Start

May 1, 2013

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

November 9, 2016

Record last verified: 2016-11

Locations

TU(1)