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

Respiration, Artificial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01950949
• Other study ID #: plaghaoc001
• Status: Completed
• Phase: N/A
• First received: July 26, 2013
• Last updated: September 17, 2015
• Start date: July 2012
• Est. completion date: May 2015

Study information

• Verified date: September 2015
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: May 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Respiration, Artificial

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yi Liu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	invasive arterial blood pressure as a Measure of Safety	if instability of circulation, stop the clinical trial	Day 1	Yes