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PEEP Levels on Intraabdominal Pressure and Hemodynamics in Critically Ill Patients

Primary Purpose

Intraabdominal Hypertension, Critically Ill, Hemodynamic Instability

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intraabdominal Pressure Measurement
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intraabdominal Hypertension focused on measuring Critically ill patients, intraabdominal pressure, hemodynamics, positive end-expiratory pressure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age between 18-80,
  • connected to mechanical ventilator in intensive care,
  • had not undergone surgery of the abdomen,
  • patients followed at the same PEEP levels for at least 24 hours

Exclusion Criteria:

  • The consent for the study,
  • initial intrabdominal pressure level is over 12 cmH2O,
  • undergoing abdominal surgery or bladder surgery,
  • neurogenic bladder,
  • morbid obesity,
  • Chronic Obstructive Pulmonary Disease Patients were excluded from the study.

Sites / Locations

  • Van yuzuncu Yıl University, Dursun Odabas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 4

Group 8

Group 12

Arm Description

Patients who received 0-4 cmH2O PEEP in mechanical ventilation were referred to as Group 4. Intraabdominal, central venous, arterial blood pressures, pulse rates, peripheric oxygen saturation, body temperature, instant fluid balances and amounts of urine (in ml/kg/hour unit) of the patients were measured on the 0. 6. 12. 18. and 24. hours and recorded.

Patients who received 5-8 cmH2O PEEP in mechanical ventilation were referred to as Group 8. Intraabdominal, central venous, arterial blood pressures, pulse rates, peripheric oxygen saturation, body temperature, instant fluid balances and amounts of urine (in ml/kg/hour unit) of the patients were measured on the 0. 6. 12. 18. and 24. hours and recorded.

Patients who received 9-12 cmH2O PEEP in mechanical ventilation were referred to as Group 12. Intraabdominal, central venous, arterial blood pressures, pulse rates, peripheric oxygen saturation, body temperature, instant fluid balances and amounts of urine (in ml/kg/hour unit) of the patients were measured on the 0. 6. 12. 18. and 24. hours and recorded.

Outcomes

Primary Outcome Measures

measure intraabdominal pressure
Intraabdominal Pressure Measurement In this method, a sterile set system (AbViser- Wolfe Tory Medical, Saik Lake City, Utah, USA) was used in normal conditions. Measurements will be made in 20 ml saline was given, Pressure transducer was used as a reset point pubic symphysis and intra-abdominal pressure was measured.

Secondary Outcome Measures

Full Information

First Posted
October 17, 2018
Last Updated
October 17, 2018
Sponsor
Yuzuncu Yıl University
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1. Study Identification

Unique Protocol Identification Number
NCT03714724
Brief Title
PEEP Levels on Intraabdominal Pressure and Hemodynamics in Critically Ill Patients
Official Title
The Effects of Various PEEP (Positive End-expiratory Pressure) Levels on Intraabdominal Pressure and Hemodynamics in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, it was aimed to compare the effects of three different PEEP levels (0-4, 5-8, 9-12 cmH2O) on intraabdominal pressure and hemodynamic parameters of patients in intensive care unit.
Detailed Description
Patients between 18-80 years old whom were mechanically ventilated without any spontaneous respiratory efforts on supine position were included into the study. Bladder pressure measurement as a practical and frequently preferred method was used in order to measure intra-abdominal pressure. 100 ml isotonic fluid was given during the measurement. Level of symphysis pubis was chosen for zeroing the pressure transducer to measure the intra-abdominal pressure. Three patient groups, each containing 22 cases, totally 66 patients were planned in this study. All patients were mechanically ventilated with various PEEP levels. The patients with 0-4 cmH2O PEEP levels were named Group 4; the patients with 5-8 cmH2O PEEP levels were named Group 8; the patients with 9-12 cmH2O PEEP levels were named Group 12. The levels of patients' PEEP levels were arranged by the responsible intensive care physician regarding to the patients' clinic. Intraabdominal, central venous, arterial blood pressures, pulse rates, peripheric oxygen saturation, body temperature, instant fluid balances and amounts of urine (in ml/kg/hour unit) of the patients were measured on the 0. 6. 12. 18. and 24. hours and recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraabdominal Hypertension, Critically Ill, Hemodynamic Instability
Keywords
Critically ill patients, intraabdominal pressure, hemodynamics, positive end-expiratory pressure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intraabdominal pressure of the patients were measured on the 0. 6. 12. 18. and 24. hours and recorded.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
Patients who received 0-4 cmH2O PEEP in mechanical ventilation were referred to as Group 4. Intraabdominal, central venous, arterial blood pressures, pulse rates, peripheric oxygen saturation, body temperature, instant fluid balances and amounts of urine (in ml/kg/hour unit) of the patients were measured on the 0. 6. 12. 18. and 24. hours and recorded.
Arm Title
Group 8
Arm Type
Active Comparator
Arm Description
Patients who received 5-8 cmH2O PEEP in mechanical ventilation were referred to as Group 8. Intraabdominal, central venous, arterial blood pressures, pulse rates, peripheric oxygen saturation, body temperature, instant fluid balances and amounts of urine (in ml/kg/hour unit) of the patients were measured on the 0. 6. 12. 18. and 24. hours and recorded.
Arm Title
Group 12
Arm Type
Active Comparator
Arm Description
Patients who received 9-12 cmH2O PEEP in mechanical ventilation were referred to as Group 12. Intraabdominal, central venous, arterial blood pressures, pulse rates, peripheric oxygen saturation, body temperature, instant fluid balances and amounts of urine (in ml/kg/hour unit) of the patients were measured on the 0. 6. 12. 18. and 24. hours and recorded.
Intervention Type
Diagnostic Test
Intervention Name(s)
Intraabdominal Pressure Measurement
Intervention Description
In this method, a sterile set system (AbViser- Wolfe Tory Medical, Saik Lake City, Utah, USA) was used in normal conditions. Measurements will be made in 20 ml saline was given, Pressure transducer was used as a reset point pubic symphysis and intra-abdominal pressure was measured.
Primary Outcome Measure Information:
Title
measure intraabdominal pressure
Description
Intraabdominal Pressure Measurement In this method, a sterile set system (AbViser- Wolfe Tory Medical, Saik Lake City, Utah, USA) was used in normal conditions. Measurements will be made in 20 ml saline was given, Pressure transducer was used as a reset point pubic symphysis and intra-abdominal pressure was measured.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between 18-80, connected to mechanical ventilator in intensive care, had not undergone surgery of the abdomen, patients followed at the same PEEP levels for at least 24 hours Exclusion Criteria: The consent for the study, initial intrabdominal pressure level is over 12 cmH2O, undergoing abdominal surgery or bladder surgery, neurogenic bladder, morbid obesity, Chronic Obstructive Pulmonary Disease Patients were excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nureddin Yüzkat
Organizational Affiliation
Yuzuncu Yıl University
Official's Role
Study Chair
Facility Information:
Facility Name
Van yuzuncu Yıl University, Dursun Odabas Medical Center
City
Van
ZIP/Postal Code
65080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28631764
Citation
Marini M, Caretta G, Vagnarelli F, Luca F, Biscottini E, Lavorgna A, Procaccini V, Riva L, Vianello G, Aspromonte N, Mortara A, De Maria R, Capasso P, Valente S, Gulizia MM. [Hemodynamic effects of positive end-expiratory pressure]. G Ital Cardiol (Rome). 2017 Jun;18(6):505-512. doi: 10.1714/2700.27611. Italian.
Results Reference
result
PubMed Identifier
20663183
Citation
Verzilli D, Constantin JM, Sebbane M, Chanques G, Jung B, Perrigault PF, Malbrain M, Jaber S. Positive end-expiratory pressure affects the value of intra-abdominal pressure in acute lung injury/acute respiratory distress syndrome patients: a pilot study. Crit Care. 2010;14(4):R137. doi: 10.1186/cc9193. Epub 2010 Jul 21.
Results Reference
result

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PEEP Levels on Intraabdominal Pressure and Hemodynamics in Critically Ill Patients

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