Comparison of Intraabdominal Pressure (IAP)

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.

Study Overview

• Status: Unknown
• Conditions: Prone Position
• Intervention / Treatment: Device: Chest roll; Device: Wilson frame; Device: Jackson surgical table

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 Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-799
    • Recruiting
    • Seoul National University of Hospital
    • Contact: Hee Pyung Park, MD PhD; Phone Number: 82-2-2072-2466; Email: hppark@snu.ac.kr
    • Contact: Eugene Kim, MD; Phone Number: 82-2-2072-3108; Email: tomomie@hanmail.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group C; Group C means active comparator group which use chest rolls intraoperatively for prone position.	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.
Active Comparator: Group W; Group W means experimental group which use Wilson frame intraoperatively for prone position.	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.
Experimental: Group J; Group J means experimental group which use Jackson surgical table intraoperatively for prone position.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	5 minute after prone position
Hemodynamic change	Check the hemodynamic changes according to PEEP change : 0,3,6 and 9 cmH2O	1min after PEEP change

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated blood loss (EBL)	Compare the EBL among the groups.	intraoperatively

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Director: Hee Pyung Park, MD PhD, professor; Principal Investigator: Eugene Kim, MD, Clinical Instuctor

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): September 1, 2014

Study Registration Dates

• First Submitted: March 20, 2014
• First Submitted That Met QC Criteria: March 20, 2014
• First Posted (Estimate): March 24, 2014

Study Record Updates

• Last Update Posted (Estimate): March 24, 2014
• Last Update Submitted That Met QC Criteria: March 20, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Intra-abdominal pressure; Prone position; Respiratory system compliance; Jackson table; Wilson frame; Chest roll
• Other Study ID Numbers: IAP_protocol