Prone PositionIAPNCT02094976
Comparison of Intraabdominal Pressure
A study testing Jackson surgical table, Wilson frame and Chest roll in people with Prone Position, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Increased intra-abdominal pressure(IAP) might influence on perioperative morbidity related to increased CVP, PVWP, SVR, PAP and decreased venous return and cardiac output. Prone position has been known to increase IAP. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Prone Position
- What is being tested?
- Jackson surgical table, Wilson frame and Chest roll
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Sep 2014
- 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 who are scheduled for prone positioned spinal surgery
- ASA Physical Status Classification System class I or II
Who cannot join
- Patients who did not agree
- BMI > 30kg/m2
- Patients who did not insert urinary foley catheter
- Patients who have COPD or emphysema
- Patients who have severe spine deformities such as scoliosis
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University of Hospital
Seoul, 110-799
Hee Pyung Park, MD PhD, 82-2-2072-2466, hppark@snu.ac.kr
Eugene Kim, MD, 82-2-2072-3108, tomomie@hanmail.net
About this study
Official title: Comparison of Intraabdominal Pressure and Respiratory Parameter Changes According to Positional Apparatus in the Prone Position
Increased intra-abdominal pressure(IAP) might influence on perioperative morbidity related to increased CVP, PVWP, SVR, PAP and decreased venous return and cardiac output. Prone position has been known to increase IAP. In clinical field, various apparatuses has developed to minimize IAP elevation during prone position operation.
In this study, we would compare the changes of IAP and respiratory system compliance according to positional apparatus in prone position.
Read the detailed description
In clinical field, Wison frame, chest rolls and Jackson table have been widely used for prone position surgery. Among those apparatus, Jackson table has padded supports under the chest and pelvis, so that the abdomen can hang freely and prevent the abdominal compression. By reducing abdominal and thoracic pressure, Jackson table would reduce blood loss, and less effects on pulmonary mechanics. But few studies has known to compare IAP with other positioning apparatus such as Wilson frame or chest roll.
- Conditions
- Prone Position
- Being tested
- Jackson surgical table, Wilson frame, Chest roll
- Keywords
- Prone position, Intra-abdominal pressure, Respiratory system compliance, Jackson table, Wilson frame, Chest roll
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jackson surgical tableDevice
After standard total intravenous anesthesia using propofol and remifentanil continous infusion, patients were turned to the prone position on a Jackson table with two padded supports on each side. The supports were positioned under the lateral chest and at the iliac crest.
Wilson frameDevice
After standard total intravenous anesthesia using propofol and remifentanil continous infusion, patients were turned to the prone position on a Wilson frame. The supports were positioned vertically from shoulder to iliac crest.
Chest rollDevice
After standard total intravenous anesthesia using propofol and remifentanil continous infusion, patients were turned to the prone position on a chest roll. The supports were positioned vertically from shoulder to iliac crest.
| Study group | Role | What they receive |
|---|---|---|
| Group C | Active comparator | Group C means active comparator group which use chest rolls intraoperatively for prone position. Receives: Device: Chest roll |
| Group W | Active comparator | Group W means experimental group which use Wilson frame intraoperatively for prone position. Receives: Device: Wilson frame |
| Group J | Experimental | Group J means experimental group which use Jackson surgical table intraoperatively for prone position. Receives: Device: Jackson surgical table |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of Intraabdominal presure (IAP)
Compare IAP changes from supine to prone according to the positional apparatus : Wilson frame, Chestrolls and Jackson table
Measured: 5 minute after position change
Secondary outcomes (3)
Changes of IAP and total respiratory system comliance (Crs) accoridng to PEEP change
Compare IAP and Crs according to PEEP changes in each group. PEEP applied 0,3,6 and 9 cm H2O and recoding was done at 1min after PEEP change.
Total respiratory system compliance (Crs) = TV/(Pplat-PEEP)
Measured: 1min after PEEP change
changes of dead space ventilation after position change
After genearal anesthetic induction, arterial blood gas analyssis (ABGA)was done at supine position. And then the position was changed to prone. 5minutes after prone position change, ABGA repeated, and calculated the dead space ventilation at each point.
Dead space ventilation (Vd/Vt) = [PaCo2-PETCO2]/PaCo2
Finally, we would compare changes of dead space ventilation after position change.
Measured: 5 minute after prone position
Hemodynamic change
Check the hemodynamic changes according to PEEP change : 0,3,6 and 9 cmH2O
Measured: 1min after PEEP change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prone PositionStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Pyoung Park, Seoul National University Hospital
- Investigators
- Hee Pyung Park, MD PhD, Study director, ProfessorEugene Kim, MD, Principal investigator, Clinical Instuctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094976
- Sponsor's protocol ID
- IAP_protocol
- Acronym
- IAP
- Status last verified
- Mar 2014
- First submitted
- 20 Mar 2014
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraabdominal Pressure and Respiratory Parameter Changes According to Positional Apparatus in the Prone Position
- ClinicalTrials.gov ID
- NCT02094976
- Acronym / sponsor ID
- IAP / IAP_protocol
- Conditions
- Prone Position
- Keywords
- Prone position, Intra-abdominal pressure, Respiratory system compliance, Jackson table, Wilson frame, Chest roll
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (estimated)
- First posted
- 24 Mar 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.
Increased intra-abdominal pressure(IAP) might influence on perioperative morbidity related to increased CVP, PVWP, SVR, PAP and decreased venous return and cardiac output. Prone position has been known to increase IAP. In clinical field, various apparatuses has developed to minimize IAP elevation during prone position operation.
In this study, we would compare the changes of IAP and respiratory system compliance according to positional apparatus in prone position.
Detailed description
In clinical field, Wison frame, chest rolls and Jackson table have been widely used for prone position surgery. Among those apparatus, Jackson table has padded supports under the chest and pelvis, so that the abdomen can hang freely and prevent the abdominal compression. By reducing abdominal and thoracic pressure, Jackson table would reduce blood loss, and less effects on pulmonary mechanics. But few studies has known to compare IAP with other positioning apparatus such as Wilson frame or chest roll.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C | Active comparator | Device: Chest rollGroup C means active comparator group which use chest rolls intraoperatively for prone position. |
| Group W | Active comparator | Device: Wilson frameGroup W means experimental group which use Wilson frame intraoperatively for prone position. |
| Group J | Experimental | Device: Jackson surgical tableGroup J means experimental group which use Jackson surgical table intraoperatively for prone position. |
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 who are scheduled for prone positioned spinal surgery
- ASA Physical Status Classification System class I or II
Key exclusion criteria (5 listed)
- Patients who did not agree
- BMI > 30kg/m2
- Patients who did not insert urinary foley catheter
- Patients who have COPD or emphysema
- Patients who have severe spine deformities such as scoliosis
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 |
|---|---|---|
| Jackson surgical tableAfter standard total intravenous anesthesia using propofol and remifentanil continous infusion, patients were turned to the prone position on a Jackson table with two padded supports on each side. The supports were positioned under the lateral chest and at the iliac crest. | Device | Group J |
| Wilson frameAfter standard total intravenous anesthesia using propofol and remifentanil continous infusion, patients were turned to the prone position on a Wilson frame. The supports were positioned vertically from shoulder to iliac crest. | Device | Group W |
| Chest rollAfter standard total intravenous anesthesia using propofol and remifentanil continous infusion, patients were turned to the prone position on a chest roll. The supports were positioned vertically from shoulder to iliac crest. | Device | Group C |
Primary outcome
changes of Intraabdominal presure (IAP)
Time frame: 5 minute after position change
Compare IAP changes from supine to prone according to the positional apparatus : Wilson frame, Chestrolls and Jackson table
3 secondary outcomes
Changes of IAP and total respiratory system comliance (Crs) accoridng to PEEP change
Time frame: 1min after PEEP change
changes of dead space ventilation after position change
Time frame: 5 minute after prone position
Hemodynamic change
Time frame: 1min after PEEP change
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
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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 Pyung Park, MD PhD study director
Professor
Eugene Kim, MD principal investigator
Clinical Instuctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jackson surgical table, Wilson frame and Chest roll in people with Prone Position, 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 5 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 24 Mar 2014. 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 Hee Pyung Park, MD Phd (82-2-2072-2466, hppark@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 Intraabdominal presure (IAP) (time frame: 5 minute after position change). 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 24 Mar 2014.