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

NCT06056401 | Completed DMC

• 1 other identifier: 2022-FXY-282
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mechanical Ventilation; General Anesthesia; Urological Surgery; Robotic Surgery

Keywords

Mechanical ventilation; robot-assisted surgery

Outcome Measures

Primary Outcomes (5)

• 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)

Study Arms (2)

VCV group

EXPERIMENTAL

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

PCV group

EXPERIMENTAL

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

Interventions

record Hemodynamic variables, respiratory variables and arterial blood gas at specific times BEHAVIORAL

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 .

PCV group; VCV group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cai Xinyuan

Guangzhou, Guangdong, 510060, China

Location

Study Officials

• Wenqian Lin

  anesthesiology department of Sun Yat-sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: September 28, 2023
• Study Start: October 15, 2022
• Primary Completion: February 24, 2023
• Study Completion: February 24, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)