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

The Correlational Study of Pulse Pressure Variation in Various Tidal Volume in Mechanically Ventilated Patients Under General Anaesthesia

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.

Study Overview

• Status: Completed
• Conditions: Respiration, Artificial
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
invasive arterial blood pressure as a Measure of Safety	if instability of circulation, stop the clinical trial	Day 1

Collaborators and Investigators

• Sponsor: Yi Liu

Publications and helpful links

General Publications

• Liu Y, Lou JS, Mi WD, Yuan WX, Fu Q, Wang M, Qu J. Pulse pressure variation shows a direct linear correlation with tidal volume in anesthetized healthy patients. BMC Anesthesiol. 2016 Sep 8;16:75. doi: 10.1186/s12871-016-0233-y.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: July 26, 2013
• First Submitted That Met QC Criteria: September 23, 2013
• First Posted (Estimate): September 26, 2013

Study Record Updates

• Last Update Posted (Estimate): September 18, 2015
• Last Update Submitted That Met QC Criteria: September 17, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Plasma Substitutes; Blood Substitutes; Hydroxyethyl Starch Derivatives
• Other Study ID Numbers: plaghaoc001