Effects of Positive End-expiratory Pressure and Tidal Volume on Fluid Responsiveness of Acute Respiratory Distress Syndrome

NCT01716962 | Unknown

• 1 other identifier: CGMF IRB 100-4473A3
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Fluid responsiveness (FR)refers to the ability of heart to increase its stroke volume in response to volume load.Low tidal volume and high PEEP exerts contrast effect on the prediction of fluid responsiveness, the aim of this study is to compare the relative predicting power of the dynamic preload indicator (PPV, SVV), passive leg raising test, and pleth variability index (PVI) on the fluid responsiveness of acute respiratory distress syndrome ventilated with various PEEP levels or various tidal volumes.

Conditions

Respiratory Distress Syndrome, Adult

Keywords

Acute respiratory distress syndrome, Fluid responsiveness, Pulse pressure variation; Pleth variability index, Passive leg raising test

Outcome Measures

Primary Outcomes (1)

• increase of cardiac output after volume expansion

  Patients are classified to be volume expansion responders or nonresponders according to whether the volume expansion induced cardiac index increase at the end of hydroxyethyl starch infusion is ≧15% or \< 15% of baseline cardiac index.

  4 hours

Study Arms (1)

ARDS with acute circulatory failure

acute respiratory distress syndrome with acute circulatory failure with infusion of 6% tetrastarch for a total of 500ml

Other: Infusion of 6% tetrastarch for a total of 500 ml

Interventions

Infusion of 6% tetrastarch for a total of 500 ml OTHER

ARDS with acute circulatory failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

mechanically ventilated ALL/ARDS patients conforming to the American European Consensus Conference criteria with acute circulatory failure for whom the attending clinician had decided to administer fluid will be enrolled.This decision was based on the presence of at least one clinical sign of inadequate tissue perfusion in the absence of contraindication for fluid infusion.

You may qualify if:

• systolic blood pressure\< 9 mmHg(or a decrease \> 50 mmHg in previously hypertensive patients)
• need of vasopressive drugs(dopamine \> 5 ug/Kg/min or norepinephrine)
• urine output\<0.5 mL/Kg/hr for at least 2 hrs
• tachycardia (heart rate \>100/min)
• presence of skin mottling.

You may not qualify if:

• patient with spontaneous respiratory activity
• cardiac arrhythmia
• known intracardiac shunt
• contraindication for passive leg raising(PLR),e.g.,pelvic trauma
• unstable spine injuries or leg amputation
• hemodynamic instability during the procedure,defined by a variation in heart rate or blood pressure of\>10%over the 15-min period before starting the protocol
• Patients of renal failure necessitate renal replacement therapy will be excluded also.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, Taiwan, 10507, Taiwan

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Chung-Chi Huang, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Respiratory Therapy, Chang Gung University

Study Record Dates

• First Submitted: October 26, 2012
• First Posted: October 30, 2012
• Study Start: November 1, 2012
• Primary Completion: July 1, 2014
• Last Updated: December 3, 2012

Record last verified: 2012-11

Locations

TW (1)