PEEP Levels on Intraabdominal Pressure and Hemodynamics in Critically Ill Patients

The Effects of Various PEEP (Positive End-expiratory Pressure) Levels on Intraabdominal Pressure and Hemodynamics in Critically Ill Patients

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.

Study Overview

• Status: Completed
• Conditions: Critically Ill; Hemodynamic Instability; Intraabdominal Hypertension
• Intervention / Treatment: Diagnostic test: Intraabdominal Pressure Measurement

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Van, Turkey, 65080
    • Van Yüzüncü Yıl University, Dursun Odabaş Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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 4; 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.	Diagnostic test: 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.
Active Comparator: Group 8; 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.	Diagnostic test: 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.
Active Comparator: Group 12; 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.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University
• Investigators: Study Chair: Nureddin Yüzkat, Yuzuncu Yıl University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 10, 2018

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 22, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 17, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: hemodynamics; Critically ill patients; positive end-expiratory pressure; intraabdominal pressure
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Musculoskeletal Diseases; Muscular Diseases; Compartment Syndromes; Critical Illness; Intra-Abdominal Hypertension
• Other Study ID Numbers: PEEP and IAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No