Hypotension on InductionPVINCT03439007
Anesthesia-induced Hypotension and Fluid Responsiveness
An observational study of Hypotension on Induction, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to find out which of the variables related to fluid responsiveness (e. g., perfusion index [PI], pleth variability index [PVI], pulse oximetry plethysmographic variance [ΔPOP]) can best predict hypotension during induction of anesthesia. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Hypotension on Induction
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Feb 2018to 1 Dec 2018
- Phase
- Observational
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 3-6 years
Who may be able to join
- Children aged 3-6 years
- Scheduled to undergo elective surgery under general anesthesia
Who cannot join
- American Society of Anesthesiologists (ASA) physical status classification III or more
- Contraindication of laryngeal mask airway (LMA) insertion:
- Esophagitis, gastritis, peptic ulcer, pyloric or intestinal stenosis, history of upper gastrointestinal tract surgery, body mass index [BMI] > 30, expected anesthesia time > 2 hours)
- Arrhythmia
- Left ventricular failure (ejection fraction < 40%)
- Congenital syndromes which are known to affect cardiopulmonary function
- Use of inotropics/vasopressors before anesthesia
- History of allergic reaction to drugs used in general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Hypotension During Induction of Anesthesia in Pediatric Patients Using Dynamic Variables of Fluid Responsiveness
The purpose of this study is to find out which of the variables related to fluid responsiveness (e. g., perfusion index [PI], pleth variability index [PVI], pulse oximetry plethysmographic variance [ΔPOP]) can best predict hypotension during induction of anesthesia.
Read the detailed description
Propofol is a widely used intravenous agent for induction of anesthesia in children aged 3 years and more. A well-known adverse effect of propofol is hypotension, which can be properly dealt with hydration and/or administration of inotropics and vasopressors. However, severe hypotension during anesthetic induction may not be immediately cured if anesthesiologist should concentrate on ventilation of the patient. Since pediatric patients have smaller reservoir for oxygen supply and perfusion to various organs of the body, delayed handling of severe hypotension may result in irreversible damage to the vital organs.
Hypotension during anesthesia is caused, though not entirely, by dehydration. There are a variety of non-invasive variables that are related to the severity of dehydration, but which of the variables can best predict anesthesia-induced hypotension in pediatric patients. In this study, we will measure the preoperative values of non-invasive variables related to fluid status, and find out which of them are most closely related to the occurrence of hypotension during anesthesia induction.
- Conditions
- Hypotension on Induction
- Keywords
- Dehydration
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypotensive | A group of pediatric patients who showed hypotension during induction of anesthesia | |
| Normotensive | A group of pediatric patients who did not show hypotension during induction of anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pleth variability index
pleth variability index
Measured: changes for 10 minutes
Secondary outcomes (7)
Adverse event_1
bradycardia
Measured: 10 minutes
Adverse event_2
hypotention
Measured: 10 minutes
Adverse event_3
EEG changes
Measured: 10 minutes
Adverse event_4
desaturation < 95%
Measured: 10 minutes
Heart rate
heart rate
Measured: changes for 10 minutes
perfusion index
perfusion index
Measured: changes for 10 minutes
pulse oximetry plethysmograpic variance
pulse oximetry plethysmograpic variance
Measured: changes for 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start10 Feb 2018
- Primary completion30 Oct 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension on InductionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
- Investigators
- Hee-Soo Kim, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439007
- Sponsor's protocol ID
- 1712-091-907
- Acronym
- PVI
- Status last verified
- Apr 2019
- First submitted
- 27 Jan 2018
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Hypotension During Induction of Anesthesia in Pediatric Patients Using Dynamic Variables of Fluid Responsiveness
- ClinicalTrials.gov ID
- NCT03439007
- Acronym / sponsor ID
- PVI / 1712-091-907
- Conditions
- Hypotension on Induction
- Keywords
- Dehydration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 20 Feb 2018 (actual)
- 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 which of the variables related to fluid responsiveness (e. g., perfusion index [PI], pleth variability index [PVI], pulse oximetry plethysmographic variance [ΔPOP]) can best predict hypotension during induction of anesthesia.
Detailed description
Propofol is a widely used intravenous agent for induction of anesthesia in children aged 3 years and more. A well-known adverse effect of propofol is hypotension, which can be properly dealt with hydration and/or administration of inotropics and vasopressors. However, severe hypotension during anesthetic induction may not be immediately cured if anesthesiologist should concentrate on ventilation of the patient. Since pediatric patients have smaller reservoir for oxygen supply and perfusion to various organs of the body, delayed handling of severe hypotension may result in irreversible damage to the vital organs.
Hypotension during anesthesia is caused, though not entirely, by dehydration. There are a variety of non-invasive variables that are related to the severity of dehydration, but which of the variables can best predict anesthesia-induced hypotension in pediatric patients. In this study, we will measure the preoperative values of non-invasive variables related to fluid status, and find out which of them are most closely related to the occurrence of hypotension during anesthesia induction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypotensive | – | –A group of pediatric patients who showed hypotension during induction of anesthesia |
| Normotensive | – | –A group of pediatric patients who did not show hypotension during induction of anesthesia |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 3-6 years
Key inclusion criteria (2 listed)
- Children aged 3-6 years
- Scheduled to undergo elective surgery under general anesthesia
Key exclusion criteria (8 listed)
- American Society of Anesthesiologists (ASA) physical status classification III or more
- Contraindication of laryngeal mask airway (LMA) insertion:
- Arrhythmia
- Left ventricular failure (ejection fraction < 40%)
- Congenital syndromes which are known to affect cardiopulmonary function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pleth variability index
Time frame: changes for 10 minutes
pleth variability index
7 secondary outcomes
Adverse event_1
Time frame: 10 minutes
Adverse event_2
Time frame: 10 minutes
Adverse event_3
Time frame: 10 minutes
Adverse event_4
Time frame: 10 minutes
Heart rate
Time frame: changes for 10 minutes
perfusion index
Time frame: changes for 10 minutes
pulse oximetry plethysmograpic variance
Time frame: changes for 10 minutes
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 12 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
Hee-Soo Kim principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension on Induction, 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 8 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 12 Apr 2019. 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?
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?
Pleth variability index (time frame: changes for 10 minutes). 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 12 Apr 2019; AzTrials last refreshed its copy on 29 Oct 2026.