Comparison of Intraabdominal Pressure

NCT ID: NCT02094976

Last Updated: 2014-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Brief Summary

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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

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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

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Prone Position

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group C

Group C means active comparator group which use chest rolls intraoperatively for prone position.

Group Type ACTIVE_COMPARATOR

Chest roll

Intervention Type DEVICE

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.

Group W

Group W means experimental group which use Wilson frame intraoperatively for prone position.

Group Type ACTIVE_COMPARATOR

Wilson frame

Intervention Type DEVICE

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.

Group J

Group J means experimental group which use Jackson surgical table intraoperatively for prone position.

Group Type EXPERIMENTAL

Jackson surgical table

Intervention Type DEVICE

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.

Interventions

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Jackson surgical table

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.

Intervention Type DEVICE

Wilson frame

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.

Intervention Type DEVICE

Chest roll

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who are scheduled for prone positioned spinal surgery
* ASA Physical Status Classification System class I or II

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee-Pyoung Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hee Pyung Park, MD PhD

Role: STUDY_DIRECTOR

Professor

Eugene Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Instuctor

Locations

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Seoul National University of Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hee Pyung Park, MD Phd

Role: CONTACT

82-2-2072-2466

Eugene Kim, MD

Role: CONTACT

82-2-2072-3108

Facility Contacts

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Hee Pyung Park, MD PhD

Role: primary

82-2-2072-2466

Eugene Kim, MD

Role: backup

82-2-2072-3108

Other Identifiers

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IAP_protocol

Identifier Type: -

Identifier Source: org_study_id

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