The Effects of Positive End-expiratory Pressure (PEEP) on Optic Nerve Sheath Diameter in Laparoscopic Cholecystectomy

NCT06979999 | Recruiting

• 1 other identifier: 2024/54
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective interventional study will evaluate the effects of applying positive end-expiratory pressure (PEEP) at 10 cmH₂O on optic nerve sheath diameter (ONSD) in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. A total of approximately 80 adult patients (ASA physical status I-III) will be included following informed consent. ONSD will be measured using a high-frequency linear ultrasound probe at three predefined intraoperative time points: (T0) 10 minutes after initiation of mechanical ventilation, (T1) 10 minutes after pneumoperitoneum creation, and (T2) 30 minutes after pneumoperitoneum creation. Dynamic lung compliance, peak airway pressure (Ppeak), end-tidal CO₂ (EtCO₂), heart rate, mean arterial pressure, and SpO₂ will also be recorded. The aim is to assess whether the application of PEEP influences intracranial pressure indicators, particularly ONSD, during laparoscopic procedures. The study may provide valuable insights into the neurophysiological effects of intra-abdominal pressure and mechanical ventilation strategies in surgical patients.

Conditions

Positive End-expiratory Pressure (PEEP); Intracranial Pressure; Optic Nerve Sheath Diameter; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• Change in Optic Nerve Sheath Diameter (ONSD)

  ONSD will be measured via ultrasound at 3 time points during surgery.

  Intraoperative; T0, T1, T2

Secondary Outcomes (5)

• Change in Peak Airway Pressure (Ppeak)

  Intraoperative measurement at T0, T1, and T2

• Change in Dynamic Lung Compliance

  Intraoperative measurement at T0, T1, and T2

• Change in End-Tidal Carbon Dioxide (EtCO₂)

  Intraoperative measurement at T0, T1, and T2

• Changes in Heart Rate (HR) and Mean Arterial Pressure (MAP) Time Frame

  Intraoperative measurement at T0, T1, and T2

• Peripheral Oxygen Saturation (SpO₂)

  Intraoperative continuous monitoring and recorded at T0, T1, and T2

Study Arms (1)

PEEP Group

EXPERIMENTAL

This arm includes patients undergoing laparoscopic cholecystectomy under general anesthesia. All participants receive 10 cmH₂O PEEP after pneumoperitoneum creation, and optic nerve sheath diameter (ONSD) is measured intraoperatively at predefined time points.

Procedure: Positive End-Expiratory Pressure (PEEP)

Interventions

Positive End-Expiratory Pressure (PEEP) PROCEDURE

Application of 10 cmH₂O PEEP during mechanical ventilation after pneumoperitoneum creation in patients undergoing laparoscopic cholecystectomy.

PEEP Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adult patients (age ≥ 18 years)
• American Society of Anesthesiologists (ASA) physical status I-III
• Scheduled for elective laparoscopic cholecystectomy under general anesthesia
• Signed informed consent

You may not qualify if:

• resence of acute or chronic eye disease
• Uncontrolled hypertension
• Asthma or known chronic pulmonary disease
• Any neurological disorders
• Body mass index (BMI) \> 35 kg/m²
• Use of medications known to affect intracranial pressure
• Refusal to participate after signing informed consent

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Niğde Training and Research Hospital

Niğde, Niğde Province, 5200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 20, 2025
• Study Start: April 29, 2024
• Primary Completion: May 29, 2025
• Study Completion: July 29, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)