A Comparative Study of Ventilation Strategies in Different Surgical Positions on Intracranial Pressure and Cerebral Blood Flow During Laparoscopic Surgery

NCT06805747 | Not Yet Recruiting DMC

• 1 other identifier: 2024-MER-312
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to investigate the effects of laparoscopic surgery in the Trendelenburg and Reverse Trendelenburg positions, and variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and pressure-controlled ventilation (PCV) on esophageal pressure, airway pressure, tidal volume, intracranial pressure, and cerebral blood flow. The study aims to address the following primary questions:Does laparoscopic surgery in the Trendelenburg or Reverse Trendelenburg position increase esophageal pressure, airway pressure, and intracranial pressure, and decrease tidal volume and cerebral blood flow? Do variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), or pressure-controlled ventilation (PCV) increase esophageal pressure, airway pressure, and intracranial pressure, and decrease tidal volume and cerebral blood flow? The investigators will compare variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and pressure-controlled ventilation (PCV) to determine which ventilation mode results in the least physiological disturbance for patients. Participant Procedures: Participants will: Be positioned according to the surgical requirements.Be randomly assigned to mechanical ventilation with either variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), or pressure-controlled ventilation (PCV). Undergo assessments at the following time points: immediately after endotracheal intubation, immediately after pneumoperitoneum, immediately after position change (Trendelenburg or Reverse Trendelenburg), 30 minutes after position change, and 1 hour after position change. Have their esophageal pressure, airway pressure, intracranial pressure, tidal volume, and internal jugular vein blood flow recorded at each assessment time point.

Conditions

Laparoscopic Surgery

Outcome Measures

Primary Outcomes (5)

• esophageal pressure

  immediately after tracheal intubation

• airway pressure

  immediately after tracheal intubation

• intracranial pressure

  immediately after pneumoperitoneum

• tidal volume

  immediately after tracheal intubation

• carotid blood flow

  half an hour after change of position

Study Arms (8)

T-V-VCV Group

EXPERIMENTAL

Variable tidal volume ventilation (V-VCV) ：The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt\_max) and minimum tidal volume (Vt\_min) were set at 10-20% of the basal tidal volume (Vt\_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 41%. Use of the trendelenburg position：Lower the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt.

Other: Variable tidal volume ventilation (V-VCV); Other: Trendelenburg position

T-PRVC Group

EXPERIMENTAL

Pressure-regulated volume-controlled ventilation (PRVC) ：The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW), the upper limit of peak inspiratory pressure was 30 cmH2O, the maximum tidal volume (Vt\_max) and the minimum tidal volume (Vt\_min) was set at 10-20% of the base tidal volume (Vt\_base). Respiratory Rate is 12, Inspiration to Expiration Ratio is 1:2, Positive End-Expiratory Pressure (PEEP) is 5cmH2O, and Inhaled Oxygen Concentration (FiO2) is 98%. Use of the trendelenburg position：Lower the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt.

Other: Pressure-regulated volume-controlled ventilation (PRVC); Other: Trendelenburg position

T-C-VCV Group

EXPERIMENTAL

Conventional volume-controlled ventilation (C-VCV)The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt\_max) and minimum tidal volume (Vt\_min) were set at 10-20% of the basal tidal volume (Vt\_base). Respiratory Rate 12.Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 98%. Use of the trendelenburg position：Lower the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt.

Other: Conventional volume-controlled ventilation (C-VCV); Other: Trendelenburg position

T-PVC Group

EXPERIMENTAL

Pressure-controlled ventilation (PCV)：The inspiratory pressure level is set, usually with an initial value of 20 cmH2O, a respiratory rate of 12, an inspiratory/expiratory ratio of 1:2, a positive end-expiratory pressure (PEEP) of 5 cm water column, and an inspired oxygen concentration (FiO2) of 98%. Use of the trendelenburg position：Lower the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt.

Other: Pressure-controlled ventilation (PCV); Other: Trendelenburg position

R-V-VCV Group

EXPERIMENTAL

Variable tidal volume ventilation (V-VCV) ：The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt\_max) and minimum tidal volume (Vt\_min) were set at 10-20% of the basal tidal volume (Vt\_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 41%. Use of the reverse trendelenburg position：Elevate the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt.

Other: Variable tidal volume ventilation (V-VCV); Other: Reverse Trendelenburg position

R-PRVC Group

EXPERIMENTAL

Pressure-regulated volume-controlled ventilation (PRVC) ：The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW), the upper limit of peak inspiratory pressure was 30 cmH2O, the maximum tidal volume (Vt\_max) and the minimum tidal volume (Vt\_min) was set at 10-20% of the base tidal volume (Vt\_base). Respiratory Rate is 12, Inspiration to Expiration Ratio is 1:2, Positive End-Expiratory Pressure (PEEP) is 5cmH2O, and Inhaled Oxygen Concentration (FiO2) is 98%. Use of the reverse trendelenburg position：Elevate the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt.

Other: Pressure-regulated volume-controlled ventilation (PRVC); Other: Reverse Trendelenburg position

R-C-VCV Group

EXPERIMENTAL

Conventional volume-controlled ventilation (C-VCV)The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt\_max) and minimum tidal volume (Vt\_min) were set at 10-20% of the basal tidal volume (Vt\_base). Respiratory Rate 12.Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 98%. Use of the reverse trendelenburg position：Elevate the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt.

Other: Conventional volume-controlled ventilation (C-VCV); Other: Reverse Trendelenburg position

R-PVC Group

EXPERIMENTAL

Pressure-controlled ventilation (PCV)：The inspiratory pressure level is set, usually with an initial value of 20 cmH2O, a respiratory rate of 12, an inspiratory/expiratory ratio of 1:2, a positive end-expiratory pressure (PEEP) of 5 cm water column, and an inspired oxygen concentration (FiO2) of 98%. Use of the reverse trendelenburg position：Elevate the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt.

Other: Pressure-controlled ventilation (PCV); Other: Reverse Trendelenburg position

Interventions

Variable tidal volume ventilation (V-VCV) OTHER

Variable tidal volume ventilation (V-VCV) ：The initial tidal volume is set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW), and the maximum tidal volume (Vt\_max) and minimum tidal volume (Vt\_min) are set at 10-20% of the base tidal volume (Vt\_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiration to Expiration Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5 cm water column, and Inhaled Oxygen Concentration (FiO2) 41%.

R-V-VCV Group; T-V-VCV Group

Pressure-regulated volume-controlled ventilation (PRVC) OTHER

Pressure-regulated volume-controlled ventilation (PRVC) ：Initial tidal volume is set at 6-8 ml/kg IBW based on Ideal Body Weight (IBW), peak inspiratory pressure is capped at 30 cmH2O, maximum tidal volume (Vt\_max), and minimum tidal volume (Vt\_min) is set at 10-20% of basal tidal volume (Vt\_base). Respiratory Rate (RR) 12, Inspiratory Breathing Ratio (IBR) 1:2, Positive End-Expiratory Pressure (PEEP) 5 cm water column, and Inhaled Oxygen Concentration (FiO2) 98%.

R-PRVC Group; T-PRVC Group

Conventional volume-controlled ventilation (C-VCV) OTHER

Conventional volume-controlled ventilation (C-VCV) ：The initial tidal volume is set at 6-8 ml/kg IBW based on Ideal Body Weight (IBW), and the maximum tidal volume (Vt\_max) and minimum tidal volume (Vt\_min) are set at 10-20% of the basal tidal volume (Vt\_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiration to Expiration Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, FiO2 98%.

R-C-VCV Group; T-C-VCV Group

Pressure-controlled ventilation (PCV) OTHER

Pressure-controlled ventilation (PCV)：Set inspiratory pressure level, usually 20 cmH2O initial value, Respiratory Rate 12, Inspiratory to Expiratory Ratio 1:2, Positive End-Expiratory Pressure (PEEP) 5 cm water column, Inhaled Oxygen Concentration (FiO2) 98%.

R-PVC Group; T-PVC Group

Trendelenburg position OTHER

Trendelenburg position：Lower the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt.

T-C-VCV Group; T-PRVC Group; T-PVC Group; T-V-VCV Group

Reverse Trendelenburg position OTHER

Reverse Trendelenburg position：Elevate the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt.

R-C-VCV Group; R-PRVC Group; R-PVC Group; R-V-VCV Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Unrestricted
• American Society of Anesthesiologists (ASA) Physical Status: Class I-III
• Surgical Position: Requires the use of either the Trendelenburg position or the Reverse Trendelenburg position during the procedure.
• Ventilation: Planned mechanical ventilation is required during the procedure, with suitability for one of the following modes: pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), or pressure-controlled ventilation (PCV).

You may not qualify if:

• Significant Cardiopulmonary Disease:
• Intracranial Disease
• Severe Coagulopathy or Current Anticoagulant Therapy
• Presence of Psychiatric Illness, Cognitive Impairment, or other condition that precludes the ability to understand or comply with the study.

Sponsors & Collaborators

• Inner Mongolia Baogang Hospital: lead

Study Sites (1)

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, 014010, China

Location

MeSH Terms

Interventions

Head-Down Tilt

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Xiaguang XG Duan, Master's degree

CONTACT

+86 13314720012; alonlord2023@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: February 3, 2025
• Study Start: February 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 10, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: January 2026-January 2036
• Access Criteria: A proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed.

Locations

CN (1)