Respiration, ArtificialNCT01950949
The Correlational Study of PPV in Various VT in Mechanically Ventilated Patients
A study testing 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 in people with Respiration, Artificial, run by Yi Liu.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Respiration, Artificial
- What is being tested?
- 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- scheduled for elective abdominal surgeries ASA (American Society of Anesthesiologists) I or II BMI 18-25 preoperative examination is normal
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Respiration, Artificial
- Being tested
- 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
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 investigationOther
| Study group | Role | What they receive |
|---|---|---|
| change respiratory parameters, volume expanding | Experimental | Not described Receives: 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 being measured
The primary outcome is the main question the study is designed to answer.
invasive arterial blood pressure as a Measure of Safety
if instability of circulation, stop the clinical trial
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startJul 2012
- Primary completionMar 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiration, ArtificialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yi Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Liu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950949
- Sponsor's protocol ID
- plaghaoc001
- Status last verified
- Sep 2015
- First submitted
- 26 Jul 2013
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 27609188
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlational Study of Pulse Pressure Variation in Various Tidal Volume in Mechanically Ventilated Patients Under General Anaesthesia
- ClinicalTrials.gov ID
- NCT01950949
- Acronym / sponsor ID
- plaghaoc001
- Conditions
- Respiration, Artificial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Yi LiuUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| change respiratory parameters, volume expanding | Experimental | 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- scheduled for elective abdominal surgeries ASA (American Society of Anesthesiologists) I or II BMI 18-25 preoperative examination is normal
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | change respiratory parameters, volume expanding |
Primary outcome
invasive arterial blood pressure as a Measure of Safety
Time frame: Day 1
if instability of circulation, stop the clinical trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
- Derived from this study: PubMed 27609188Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Respiration, Artificial, run by Yi Liu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
invasive arterial blood pressure as a Measure of Safety (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01950949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2015.