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Completed

NCT Number: NCT03714724

PEEP Levels on Intraabdominal Pressure and Hemodynamics in Critically Ill Patients

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van yuzuncu Yıl University, Dursun Odabas Medical Center

Van, 65080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intraabdominal Pressure Measurement

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.

Primary outcomes

  1. measure intraabdominal pressure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 22, 2018
Registry last updated
Oct 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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