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NCT Number: NCT02439801

Comparison of Effects of PEEP Levels on Respiratory Mechanics in Patients Undergoing Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy is accepted as gold standard in the management of cholelithiasis. Although laparoscopic procedures have many advantages,intra-abdominal CO2 insufflation can cause decreased lung volumes and compliance, increased airway resistance and impaired ventilation-perfusion ratio. In this study, investigators aim to investigate effects of intra-operative PEEP treatment at 3 distinct levels on respiratory dynamics and elimination time of volatile anesthetic agent.

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Key information

Conditions

Respiratory System Abnormalities Behavior Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Health Behavior Patient Acceptance of Health Care Patient Compliance Respiratory Tract Diseases Treatment Adherence and Compliance

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Umraniye Training Hospital

Istanbul, Turkey (Türkiye)

About this study

In the study, 75 ASA I-II patients aged 30-65 years will be randomized into 3 groups to receive 0 cmH2O PEEP (Group-1), 5 cmH2O PEEP (Group-2) and 8 cmH2O PEEP (Group-3) in PVC mode. In all patients underwent general anesthesia; hemodynamic parameters, Ppeak, Pplateau, compliance values as well as Fisevo/Fexpsevo ratio at 1 MAC and times from 1 MAC to 0.3 and 0.1 MAC will be recorded. In addition, preoperative and postoperative pulmonary function tests will be compared in all patients.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ASA (American Society of Anesthesiologists) I-II
  • BMI of 25-30
  • patients scheduled to elective laparoscopic cholecystectomy.

Exclusion criteria

  • Patients with ASA III, IV, V risk,
  • Patients with comorbid diseases that may increase intra-abdominal pressure or pulmonary hypertension,
  • Patients with renal and hepatic failure,
  • Patients with pregnancy and
  • Patients using bronchodilator or steroid were excluded.

Treatment and study plan

PEEP 0

Procedure

0 cmH2O positive end expiratory pressure

peep 5

Procedure

5 cmH2O positive end expiratory pressure

PEEP 8

Procedure

8 cmH2O positive end expiratory pressure

Primary outcomes

  1. levels of static-dynamic compliance with intra-operative PEEP treatment at 3 distinct levels

    Time frame: 1 month

Secondary outcomes

  1. elimination time of volatile anesthetic agent with intra-operative PEEP treatment at 3 distinct levels

    Time frame: 1 month

  2. levels of p peak and p plateau pressures with intra-operative PEEP treatment at 3 distinct levels

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Umraniye Education and Research Hospital

Other Gov

Registry information

Official study title

Comparison of Effects of 3 Different PEEP Levels on Hemodynamic, Respiratory Mechanics and Elimination of Volatile Anesthetic Agent in Patients Undergoing Laparoscopic Cholecystectomy

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 12, 2015
Registry last updated
May 12, 2015

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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