NCT03714724

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

8 months

First QC Date

October 17, 2018

Last Update Submit

October 17, 2018

Conditions

Keywords

Critically ill patientsintraabdominal pressurehemodynamicspositive end-expiratory pressure

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Group 4

ACTIVE COMPARATOR

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

Group 8

ACTIVE COMPARATOR

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

Group 12

ACTIVE COMPARATOR

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

Interventions

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 12Group 4Group 8

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van yuzuncu Yıl University, Dursun Odabas Medical Center

Van, 65080, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Intra-Abdominal HypertensionCritical Illness

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nureddin Yüzkat

    Yuzuncu Yil University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Intraabdominal pressure of the patients were measured on the 0. 6. 12. 18. and 24. hours and recorded.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 22, 2018

Study Start

February 1, 2018

Primary Completion

October 1, 2018

Study Completion

October 10, 2018

Last Updated

October 22, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations