PEEP Levels on Intraabdominal Pressure and Hemodynamics in Critically Ill Patients

Not Applicable

Completed

• Conditions: Critically Ill; Intraabdominal Hypertension; Hemodynamic Instability
• Interventions: Diagnostic Test: Intraabdominal Pressure Measurement

• Registration Number: NCT03714724
• Lead Sponsor: Yuzuncu Yıl University

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.

Study Timeline

• Study Start: 2018-02-01
• Status Verified: 2018-10
• Primary Completion: 2018-10-01
• Study Completion: 2018-10-10
• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-17
• Last Update Submitted: 2018-10-17
• Study First Posted: 2018-10-22
• Last Update Posted: 2018-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 12	Intraabdominal Pressure Measurement	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.
Group 8	Intraabdominal Pressure Measurement	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.
Group 4	Intraabdominal Pressure Measurement	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.

Primary Outcome Measures

Name	Time	Method
measure intraabdominal pressure	1 month	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.

Trial Locations

Locations (1)

Van yuzuncu Yıl University, Dursun Odabas Medical Center; 🇹🇷 Van, Turkey