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

Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06056401
• Other study ID #: 2022-FXY-282
• Status: Completed
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: February 24, 2023

Study information

• Verified date: September 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 24, 2023
• Est. primary completion date: February 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• General Anesthesia
• Mechanical Ventilation
• Robotic Surgery
• Urological Surgery

Intervention

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 .

Locations

Country	Name	City	State
China	Cai Xinyuan	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

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