PEEP Levels on Intraabdominal Pressure and Hemodynamics in Critically Ill Patients

Critically Ill Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03714724
• Other study ID #: PEEP and IAP
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: October 10, 2018

Study information

• Verified date: October 2018
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 10, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Hemodynamic Instability
• Intra-Abdominal Hypertension
• Intraabdominal Hypertension

Intervention

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.

Locations

Country	Name	City	State
Turkey	Van yuzuncu Yil University, Dursun Odabas Medical Center	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Marini M, Caretta G, Vagnarelli F, Lucà 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). — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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