Effects of Different Ventilation Modes on Airway Pressure and Intracranial Pressure in Patients in the Trendelenburg Position

NCT06665061 | Completed DMC FDA Device

• 4 other identifiers: 2023-MER-106No. 2024MS08058No. 2023wsjkkj120No. YKD2024LH011
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to understand the impact of three different ventilation modes-pressure-controlled ventilation (PCV), volume-controlled ventilation (VCV), and pressure-regulated volume-controlled ventilation (PRVC)-on airway pressure and intracranial pressure in patients undergoing resuscitation positioning. It aims to evaluate the effects of these ventilation modes on patients in resuscitation positions. The main questions it seeks to answer are: Does the PRVC mode more effectively control airway pressure and intracranial pressure in patients undergoing resuscitation positioning? Does it help to reduce the risk of increased intracranial pressure during surgery?

Conditions

Laparoscopic Myomectomy

Keywords

Trendelenburg Position; pressure-controlled ventilation; volume-controlled ventilation; pressure-regulated volume-controlled ventilation; Optic nerve sheath diameter

Outcome Measures

Primary Outcomes (2)

• Average Airway Pressure (PAWM) in the Trendelenburg Position

  The normal range for Average Airway Pressure (PAWM) during mechanical ventilation is 5-10 cmH2O. The higher the value, the greater the pressure, and the worse the outcome.

  Measurements will be taken at five specific time points: before and after pneumoperitoneum at 5, 10, 15, and 20 minutes.

• Optic Nerve Sheath Diameter (ONSD) as a Measure of Intracranial Pressure

  Optic Nerve Sheath Diameter (ONSD) is a non-invasive method used to assess increased intracranial pressure through ultrasonographic measurement. The normal range for ONSD is approximately between 3.3mm and 5.2mm, while a value exceeding 5mm is generally considered indicative of possible increased intracranial pressure.

  ONSD measurements will be recorded at the same five time points as PAWM: before and after pneumoperitoneum at 5, 10, 15, and 20 minutes.

Secondary Outcomes (1)

• Hemodynamic Stability as Assessed by Mean Arterial Pressure (MAP) and Heart Rate (HR)

  MAP and HR will be recorded at the same five time points as PAWM and ONSD: before and after pneumoperitoneum at 5, 10, 15, and 20 minutes.

Study Arms (3)

PCV

EXPERIMENTAL

After intubation under anesthesia, mechanical ventilation is performed in the pressure control ventilation (PCV) mode.

Device: PCV

VCV

EXPERIMENTAL

After intubation under anesthesia, mechanical ventilation is performed in the volume control ventilation (VCV) mode.

Device: VCV

PRVC

EXPERIMENTAL

After intubation under anesthesia, mechanical ventilation is performed in the pressure-regulated volume control (PRVC) mode.

Device: PRVC

Interventions

PCV DEVICE

Patients were randomly assigned to receive PCV mechanical ventilation, with consistent ventilation parameters.

PCV

VCV DEVICE

Patients were randomly assigned to receive VCV mode mechanical ventilation, with consistent ventilation parameters.

VCV

PRVC DEVICE

Patients were randomly assigned to receive PRVC mode mechanical ventilation, with consistent ventilation parameters.

PRVC

Eligibility Criteria

• Age: 22 Years - 77 Years
• Gender Eligibility Details: This study enrolled patients who underwent elective laparoscopic myomectomy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ●The patients had an ASA classification of I-III.

You may not qualify if:

• allergy to the anesthetic drugs
• liver cirrhosis
• kidney dysfunction
• cardiopulmonary impairment
• Patients were uncooperative

Sponsors & Collaborators

• Inner Mongolia Baogang Hospital: lead

Study Sites (1)

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, 014010, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The anesthesiologists and surgeons performing the anesthesia and assisting with the surgery were only informed of the mechanical ventilation mode to be used. Patients were unaware of their group assignment because mechanical ventilation was initiated after anesthesia induction when they were unconscious. The anesthetic nurses and doctors evaluating the patients postoperatively were also unaware of the group assignments.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study enrolled patients aged 27-77 years who underwent elective laparoscopic myomectomy at our institution from February 2023 to August 2024. The patients had an ASA classification of I-III. Patients were excluded if they had an allergy to the anesthetic drugs used in the study, adverse effects to the analgesics included, liver cirrhosis or kidney dysfunction, or cardiopulmonary impairment.

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: October 30, 2024
• Study Start: February 1, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: from February 2023 to August 2033
• Access Criteria: Anyone

Locations

CN (1)