Clinical trial NCT03714724: 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
Overall status: COMPLETED
Phase: NA
Conditions: Intraabdominal Hypertension
Critically Ill
Hemodynamic Instability
Keywords: Critically ill patients
intraabdominal pressure
hemodynamics
positive end-expiratory pressure
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intraabdominal pressure of the patients were measured on the 0. 6. 12. 18. and 24. hours and recorded.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: measure intraabdominal pressure
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van yuzuncu Yıl University, Dursun Odabas Medical Center
Study officials:
affiliation: Yuzuncu Yıl University
name: Nureddin Yüzkat
role: STUDY_CHAIR
References:
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.
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.