Comparison of Volume-controlled and Pressure-controlled Ventilation in Clasp-knife Position

Comparison of Volume-controlled and Pressure-controlled Ventilation in Clasp-knife Position for Robot-assisted Laparoscopic Urological Surgery

Carbon dioxide (CO2) pneumoperitoneum and clasp-knife positioning are commonly used to improve surgical access during robot-assisted laparoscopic urological surgery. However, these methods are sometimes associated with several unwanted cardiopulmonary effects such as increased mean arterial pressure, decreased pulmonary compliance and functional residual capacity, increased peak inspiratory pressure, and respiratory acidosis in association with hypercarbia. Volume-controlled ventilation (VCV) is the most commonly used method of ventilation during general anesthesia. It provides fixed minute ventilation and pulmonary resistance, which affect airway pressure. In pressure-controlled ventilation (PCV), constant inspiratory airway pressure can be achieved by decelerating the flow. However, minute ventilation is not fixed . CO2 pneumoperitoneum in the clasp-knife positioning can influence hemodynamic variables, including blood pressure, heart rate, and cardiac output. This is because changes in airway pressure affect intrathoracic pressure and the function of the heart itself. In this randomized study, we investigated the effects of VCV and PCV on peak inspiratory pressure during robot-assisted laparoscopic urological surgery involving CO2 pneumoperitoneum in the clasp-knife position.

Study Overview

• Status: Completed
• Conditions: Robotic Surgery; General Anesthesia; Mechanical Ventilation; Urological Surgery
• Intervention / Treatment: Behavioral: record Hemodynamic variables, respiratory variables and arterial blood gas at specific times

Detailed Description

After careful screening, 60 patients were enrolled in the trial. The investigators monitored patients' breathing, circulation and carbon metabolism by measuring arterial gas, cardiac output monitoring, respiratory parameters and circulation parameters at different times in both groups of patients.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Cai Xinyuan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing urological surgery in clasp-knife position
• between the age of 18 and 65
• America Society of Anesthesiologist Grades I-II.

Exclusion Criteria:

• Morbid obesity
• systolic blood pressure < 90 mmHg)
• heart rate < 60 beats per minute or > 100 beats per minute
• peripheral blood oxygen saturation < 90%
• Complicated with severe liver and kidney injury.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VCV group; For patients assigned in this group, after standard anesthesia, in which the following drugs were used (midazolam 0.05 mg / kg;propofol 1.5-2.5 mg / kg; sufentanil 0.3-0.5 μg / kg; and cisatracurium0.2-0.3 mg / kg), their mechanical ventilation mode was adjusted to the VCV mode.	Behavioral: record Hemodynamic variables, respiratory variables and arterial blood gas at specific times; Hemodynamic variables, respiratory variables and arterial blood gas were measured and recorded 15 minutes after induction of anesthesia (T1), 15 minutes after establishment of a folding knife position (T2), 30 and 60 minutes after CO2 pneumoconiosis (T3 and T4), and 15 minutes after pneumoconiosis (T5). Hemodynamic variables measured included mean arterial pressure , heart rate , cardiac output, cardiac index, stroke volume index and stroke volume variation. Breathing variables include tidal volume, minute ventilation , respiratory rate , airway frontal pressure , mean airway pressure , plateaus airway pressure , peripheral oxygen saturation , oxygen saturation , and oxygen response . Arterial blood gas variables include pH value, arterial carbon dioxide, arterial oxygen pressure , alkali surplus , alveolar oxygen pressure , and bicarbonate of soda ion concentration .
Experimental: PCV group; For patients assigned in this group, after standard anesthesia, in which the following drugs were used (midazolam 0.05 mg / kg;propofol 1.5-2.5 mg / kg; sufentanil 0.3-0.5 μg / kg; and cisatracurium0.2-0.3 mg / kg), their mechanical ventilation mode was adjusted to the PCV mode.	Behavioral: record Hemodynamic variables, respiratory variables and arterial blood gas at specific times; Hemodynamic variables, respiratory variables and arterial blood gas were measured and recorded 15 minutes after induction of anesthesia (T1), 15 minutes after establishment of a folding knife position (T2), 30 and 60 minutes after CO2 pneumoconiosis (T3 and T4), and 15 minutes after pneumoconiosis (T5). Hemodynamic variables measured included mean arterial pressure , heart rate , cardiac output, cardiac index, stroke volume index and stroke volume variation. Breathing variables include tidal volume, minute ventilation , respiratory rate , airway frontal pressure , mean airway pressure , plateaus airway pressure , peripheral oxygen saturation , oxygen saturation , and oxygen response . Arterial blood gas variables include pH value, arterial carbon dioxide, arterial oxygen pressure , alkali surplus , alveolar oxygen pressure , and bicarbonate of soda ion concentration .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Check the patient's ventilation effect at a specific time	we recorded the patients' peak inspiratory pressure	T1(15 minutes after induction of anesthesia)
Check the patient's ventilation effect at a specific time	we recorded the patients' peak inspiratory pressure	T2(15 minutes after position was changed)
Check the patient's ventilation effect at a specific time	we recorded the patients' peak inspiratory pressure	T3(30 minutes after pneumoperitoneum was established)
Check the patient's ventilation effect at a specific time	we recorded the patients' peak inspiratory pressure	T4(60 minutes after pneumoperitoneum was established)
Check the patient's ventilation effect at a specific time	we recorded the patients' peak inspiratory pressure	T5(15 minutes after pneumoperitoneum was released)

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Wenqian Lin, anesthesiology department of Sun Yat-sen University Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2022
• Primary Completion (Actual): February 24, 2023
• Study Completion (Actual): February 24, 2023

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Mechanical ventilation; robot-assisted surgery
• Other Study ID Numbers: 2022-FXY-282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No