Laparoscopic SurgeryLapa-BPNCT02536521
Predictive Variables of the Hemodynamic Effect During the Laparoscopic Surgery in Children
An observational study of Laparoscopic Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This prospective observational study aimed to identify the intraoperative variables to predict the hemodynamic change according to intra-abdominal pressure in the children undergoing laparoscopic surgery. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Laparoscopic Surgery
- How many people
- 123 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to May 2017
- 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 Up to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients undergoing laparoscopic surgery
Who may be able to join
- Pediatric patients undergoing laparoscopic surgery
Who cannot join
- known arrhythmia
- known lung disease
- known cardiac dysfunction (Ejection fraction less than 30%)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Predictive Variables Able to Predict the Hemodynamic Effect of Intra-abdominal Pressure in the Children Undergoing Laparoscopic Surgery
This prospective observational study aimed to identify the intraoperative variables to predict the hemodynamic change according to intra-abdominal pressure in the children undergoing laparoscopic surgery.
The intraoperative variables includes Pulse pressure variation (PPV), systolic pressure variation (SPV), stoke volume variation (SVV), Pulse oximeter plethysmographic waveform amplitude (△POP),and pleth variability index (PVI).
- Conditions
- Laparoscopic Surgery
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 |
|---|---|---|
| Hemodynamically stable | Not described | |
| Hemodynamically unstable | Hemodynamically unstable patients are defined as those with a 20% decrease in systolic blood pressure according to the change of intraabdominal pressure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pleth variability index(PVI)
Measured: Outcome measure will be assessed before the CO2 desufflation for about 2minutes.
Secondary outcomes (3)
Systolic pressure variation(SPV)
Measured: Outcome measure will be assessed before the CO2 desufflation for about 2minutes.
Pulse pressure variation(PPV)
Measured: Outcome measure will be assessed before the CO2 desufflation for about 2minutes
Pulse oximeter plethysmographic waveform amplitude (△POP)
Measured: Outcome measure will be assessed before the CO2 desufflation for about 2minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2017
- Study completionMay 2017
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 Laparoscopic SurgeryStudies 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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536521
- Sponsor's protocol ID
- H-1507-039-686
- Acronym
- Lapa-BP
- Status last verified
- Jun 2017
- First submitted
- 24 Aug 2015
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim EH, Lee JH, Song IK, Ryu HG, Kim HS, Kim JT. Assessment of dynamic variables of fluid responsiveness to predict desufflation-induced hypotension during paediatric laparoscopic surgery. Br J Anaesth. 2017 Nov 1;119(5):956-963. doi: 10.1093/bja/aex172.
PubMed 28981568
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Predictive Variables Able to Predict the Hemodynamic Effect of Intra-abdominal Pressure in the Children Undergoing Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT02536521
- Acronym / sponsor ID
- Lapa-BP / H-1507-039-686
- Conditions
- Laparoscopic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 1 Sep 2015 (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.
This prospective observational study aimed to identify the intraoperative variables to predict the hemodynamic change according to intra-abdominal pressure in the children undergoing laparoscopic surgery.
The intraoperative variables includes Pulse pressure variation (PPV), systolic pressure variation (SPV), stoke volume variation (SVV), Pulse oximeter plethysmographic waveform amplitude (△POP),and pleth variability index (PVI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodynamically stable | – | – |
| Hemodynamically unstable | – | –Hemodynamically unstable patients are defined as those with a 20% decrease in systolic blood pressure according to the change of intraabdominal pressure. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients undergoing laparoscopic surgery
Key inclusion criteria (1 listed)
- Pediatric patients undergoing laparoscopic surgery
Key exclusion criteria (3 listed)
- known arrhythmia
- known lung disease
- known cardiac dysfunction (Ejection fraction less than 30%)
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(PVI)
Time frame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes.
3 secondary outcomes
Systolic pressure variation(SPV)
Time frame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes.
Pulse pressure variation(PPV)
Time frame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes
Pulse oximeter plethysmographic waveform amplitude (△POP)
Time frame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes
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 15 Jun 2017.
- Derived from this study: PubMed 28981568Kim EH, Lee JH, Song IK, Ryu HG, Kim HS, Kim JT. Assessment of dynamic variables of fluid responsiveness to predict desufflation-induced hypotension during paediatric laparoscopic surgery. Br J Anaesth. 2017 Nov 1;119(5):956-963. doi: 10.1093/bja/aex172.
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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.
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 Laparoscopic Surgery, 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 1 inclusion and 3 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 15 Jun 2017. 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(PVI) (time frame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes.). 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 NCT02536521, 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 15 Jun 2017.