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The Correlational Study of PPV in Various VT in Mechanically Ventilated Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01950949
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : September 18, 2015
Sponsor:
Information provided by (Responsible Party):
Yi Liu, Chinese PLA General Hospital

Brief Summary:
Mesquida, J et al showed there was a significant linear correlation between pulse pressure variations under tidal volume 6 ml/kg and 8 ml/kg in patients after the resuscitation phase of severe sepsis and septic shock. No study revealed the actual relationship between various PPV under different VT. So we hypothesized that there were relationship between various PPV in different tidal volume settings. The objective of this study was to examine the relationship between various PPV.

Condition or disease Intervention/treatment Phase
Respiration, Artificial Other: 300 ml Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection infusing in 15 minutes if PPV under VT 8 ml/kg was larger than 13% in the initial investigation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Correlational Study of Pulse Pressure Variation in Various Tidal Volume in Mechanically Ventilated Patients Under General Anaesthesia
Study Start Date : July 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: change respiratory parameters, volume expanding Other: 300 ml Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection infusing in 15 minutes if PPV under VT 8 ml/kg was larger than 13% in the initial investigation



Primary Outcome Measures :
  1. invasive arterial blood pressure as a Measure of Safety [ Time Frame: Day 1 ]
    if instability of circulation, stop the clinical trial



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

scheduled for elective abdominal surgeries ASA (American Society of Anesthesiologists) I or II BMI 18-25 preoperative examination is normal

Exclusion Criteria:

acute lung injure acute respiratory distress syndrome cardiovascular diseases neurological disease renal or hepatic disease diabetes mellitus BMI less than 18 kg/m2 or greater than 25 kg/m2


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yi Liu, Attending of AOC, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01950949    
Other Study ID Numbers: plaghaoc001
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: September 18, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes