PEEP Levels on Intraabdominal Pressure and Hemodynamics in Critically Ill Patients

NCT ID: NCT03714724

Last Updated: 2018-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2018-10-10

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.

Conditions

Intraabdominal Hypertension; Critically Ill; Hemodynamic Instability

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Intraabdominal Pressure Measurement

Intervention Type: DIAGNOSTIC_TEST

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.

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.

Group Type: ACTIVE_COMPARATOR

Intraabdominal Pressure Measurement

Intervention Type: DIAGNOSTIC_TEST

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.

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.

Group Type: ACTIVE_COMPARATOR

Intraabdominal Pressure Measurement

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuzuncu Yıl University

OTHER

Sponsor Role: lead

Responsible Party

Nureddin YUZKAT

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nureddin Yüzkat

Role: STUDY_CHAIR

Yuzuncu Yıl University

Locations

Van yuzuncu Yıl University, Dursun Odabas Medical Center

Van, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 28631764 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20663183 (View on PubMed)

Other Identifiers

PEEP and IAP

Identifier Type: -

Identifier Source: org_study_id