Comparison of Intraabdominal Pressure

NCT02094976 | Unknown DMC

• 1 other identifier: IAP_protocol
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prone Position

Keywords

Prone position; Intra-abdominal pressure; Respiratory system compliance; Jackson table; Wilson frame; Chest roll

Outcome Measures

Primary Outcomes (1)

• changes of Intraabdominal presure (IAP)

  Compare IAP changes from supine to prone according to the positional apparatus : Wilson frame, Chestrolls and Jackson table

  5 minute after position change

Secondary Outcomes (3)

• Changes of IAP and total respiratory system comliance (Crs) accoridng to PEEP change

  1min after PEEP change

• changes of dead space ventilation after position change

  5 minute after prone position

• Hemodynamic change

  1min after PEEP change

Other Outcomes (1)

• Estimated blood loss (EBL)

  intraoperatively

Study Arms (3)

Group C

ACTIVE COMPARATOR

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

Device: Chest roll

Group W

ACTIVE COMPARATOR

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

Device: Wilson frame

Group J

EXPERIMENTAL

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

Device: Jackson surgical table

Interventions

Jackson surgical table 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.

Group J

Wilson frame 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 W

Chest roll 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 C

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University of Hospital

Seoul, 110-799, South Korea

RECRUITING

Study Officials

• Hee Pyung Park, MD PhD

  Professor

  STUDY DIRECTOR

• Eugene Kim, MD

  Clinical Instuctor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Pyung Park, MD Phd

CONTACT

82-2-2072-2466; hppark@snu.ac.kr

Eugene Kim, MD

CONTACT

82-2-2072-3108; tomomie@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 24, 2014
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Last Updated: March 24, 2014

Record last verified: 2014-03

Locations

KR (1)