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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT06056401
Collaborator
(none)
60
1
2
4.3
13.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: record Hemodynamic variables, respiratory variables and arterial blood gas at specific times
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Comparison of Volume-controlled and Pressure-controlled Ventilation in Clasp-knife Position for Robot-assisted Laparoscopic Urological Surgery
Actual Study Start Date :
Oct 15, 2022
Actual Primary Completion Date :
Feb 24, 2023
Actual Study Completion Date :
Feb 24, 2023

Arms and Interventions

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 .

Outcome Measures

Primary Outcome Measures

  1. Check the patient's ventilation effect at a specific time [T1(15 minutes after induction of anesthesia)]

    we recorded the patients' peak inspiratory pressure

  2. Check the patient's ventilation effect at a specific time [T2(15 minutes after position was changed)]

    we recorded the patients' peak inspiratory pressure

  3. Check the patient's ventilation effect at a specific time [T3(30 minutes after pneumoperitoneum was established)]

    we recorded the patients' peak inspiratory pressure

  4. Check the patient's ventilation effect at a specific time [T4(60 minutes after pneumoperitoneum was established)]

    we recorded the patients' peak inspiratory pressure

  5. Check the patient's ventilation effect at a specific time [T5(15 minutes after pneumoperitoneum was released)]

    we recorded the patients' peak inspiratory pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cai Xinyuan Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cai Xinyuan, principal investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT06056401
Other Study ID Numbers:
  • 2022-FXY-282
First Posted:
Sep 28, 2023
Last Update Posted:
Sep 28, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cai Xinyuan, principal investigator, Sun Yat-sen University

Study Results

No Results Posted as of Sep 28, 2023