HypotensionNCT02208570
Predictability of the Pulse Pressure Variation (PPV) During Spontaneous Ventilation on the Incidence of Hypotension During Induction of Anesthesia
A study testing PPV>14%, Volume loading and PPV<14% in people with Hypotension, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to find out the predictability of the pulse pressure variation during spontaneous ventilation on the incidence of hypotension during induction of anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypotension
- What is being tested?
- PPV>14%, Volume loading and PPV<14%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Dec 2016
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing general anesthesia induction with intravenous anesthesia using propofol and remifentanil
- Patients requiring invasive arterial blood pressure monitoring for the surgery
Who cannot join
- Refusal of consent
- Patients with heart disease (symptomatic valvular heart disease, intracardiac shunt, pulmonary hypertension with pulmonary systolic arterial pressure exceeding 40mmHg)
- FEV1 ≤ 50% predicted FEV1
- Patients with chronic renal failure
- ASA class IV, V, VI
- Systolic arterial blood pressure below 90mmHg before induction of anesthesia
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Jae-Hyon Bahk, 82-2-2072-0641, bahkjh@snu.ac.kr
Jae-Hyon Bahk
About this study
Official title: Predictability of the Pulse Pressure Variation During Spontaneous Ventilation on the Incidence of Hypotension During Induction of Anesthesia
The purpose of this study is to find out the predictability of the pulse pressure variation during spontaneous ventilation on the incidence of hypotension during induction of anesthesia.
- Conditions
- Hypotension
- Being tested
- PPV>14%, Volume loading, PPV<14%
- Keywords
- Hypotension during anesthesia induction
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPV>14%Other
Patients whose preoperative pulse pressure variation during spontaneous ventilation exceed 14
Volume loadingDrug
Hydroxyethyl starch solution 6ml/kg iv injection
PPV<14%Other
Patients whose preoperative pulse pressure variation during spontaneous ventilation does not exceed 14
| Study group | Role | What they receive |
|---|---|---|
| P(+)V(+) | Experimental | PPV>14% before anesthesia induction, HES 6ml/kg infused Receives: Other: PPV>14%; Drug: Volume loading |
| P(+)V(-) | Experimental | PPV>14% before anesthesia induction, no additional volume infused Receives: Other: PPV>14% |
| P(-)V(+) | Experimental | PPV<14% before anesthesia induction, HES 6ml/kg infused Receives: Drug: Volume loading; Other: PPV<14% |
| P(-)V(-) | Experimental | PPV<14% before anesthesia induction, no additional volume infused Receives: Other: PPV<14% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of heart rate and systolic arterial blood pressure from baseline values immediately before tracheal intubation
First, we measure the baseline heart rate and systolic arterial blood pressure and calculate the baseline heart rate and blood pressure.
At 3 minutes after anesthesia agent injection we record the heart rate and blood pressure, and perform endotracheal intubation. Then we calculate the percentile change of blood pressure and heart rate from the baseline values.
Measured: Three minutes after anesthesia agent injection
Secondary outcomes (2)
Changes of heart rate and systolic arterial blood pressure from baseline values, three minutes before intubation
We collect the patient's vital signs for 1 second interval during anesthesia induction. We collect the patient's heart rate and blood pressure values for three minutes before endotracheal intubation, and average the numbers. Then we compare the numbers from the baseline value and calculate the changes.
Measured: Three minutes before endotracheal intubation
Changes of heart rate and systolic arterial blood pressure from baseline values, three minutes after intubation
We collect the patient's vital signs for 1 second interval during anesthesia induction. We collect the patient's heart rate and blood pressure values for three minutes after endotracheal intubation, and average the numbers. Then we compare the numbers from the baseline value and calculate the changes.
Measured: Three minutes after endotracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208570
- Sponsor's protocol ID
- JHBahk_PPV_predictability
- Status last verified
- Apr 2016
- First submitted
- 14 Jul 2014
- Last updated
- 20 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictability of the Pulse Pressure Variation During Spontaneous Ventilation on the Incidence of Hypotension During Induction of Anesthesia
- ClinicalTrials.gov ID
- NCT02208570
- Acronym / sponsor ID
- JHBahk_PPV_predictability
- Conditions
- Hypotension
- Keywords
- Hypotension during anesthesia induction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2016 (estimated)
- First posted
- 5 Aug 2014 (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.
The purpose of this study is to find out the predictability of the pulse pressure variation during spontaneous ventilation on the incidence of hypotension during induction of anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| P(+)V(+) | Experimental | Other: PPV>14%, Drug: Volume loadingPPV>14% before anesthesia induction, HES 6ml/kg infused |
| P(+)V(-) | Experimental | Other: PPV>14%PPV>14% before anesthesia induction, no additional volume infused |
| P(-)V(+) | Experimental | Drug: Volume loading, Other: PPV<14%PPV<14% before anesthesia induction, HES 6ml/kg infused |
| P(-)V(-) | Experimental | Other: PPV<14%PPV<14% before anesthesia induction, no additional volume infused |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing general anesthesia induction with intravenous anesthesia using propofol and remifentanil
- Patients requiring invasive arterial blood pressure monitoring for the surgery
Key exclusion criteria (6 listed)
- Refusal of consent
- Patients with heart disease (symptomatic valvular heart disease, intracardiac shunt, pulmonary hypertension with pulmonary systolic arterial pressure exceeding 40mmHg)
- FEV1 ≤ 50% predicted FEV1
- Patients with chronic renal failure
- ASA class IV, V, VI
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 |
|---|---|---|
| PPV>14%Patients whose preoperative pulse pressure variation during spontaneous ventilation exceed 14 | Other | P(+)V(+), P(+)V(-) |
| Volume loadingHydroxyethyl starch solution 6ml/kg iv injection | Drug | P(+)V(+), P(-)V(+) |
| PPV<14%Patients whose preoperative pulse pressure variation during spontaneous ventilation does not exceed 14 | Other | P(-)V(+), P(-)V(-) |
Primary outcome
Changes of heart rate and systolic arterial blood pressure from baseline values immediately before tracheal intubation
Time frame: Three minutes after anesthesia agent injection
First, we measure the baseline heart rate and systolic arterial blood pressure and calculate the baseline heart rate and blood pressure. At 3 minutes after anesthesia agent injection we record the heart rate and blood pressure, and perform endotracheal intubation. Then we calculate the percentile change of blood pressure and heart rate from the baseline values.
2 secondary outcomes
Changes of heart rate and systolic arterial blood pressure from baseline values, three minutes before intubation
Time frame: Three minutes before endotracheal intubation
Changes of heart rate and systolic arterial blood pressure from baseline values, three minutes after intubation
Time frame: Three minutes after endotracheal intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPV>14%, Volume loading and PPV<14% in people with Hypotension, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae-Hyon Bahk (82-2-2072-2818, bahkjh@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of heart rate and systolic arterial blood pressure from baseline values immediately before tracheal intubation (time frame: Three minutes after anesthesia agent injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2016.