The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial

Not Applicable

Completed

• Conditions: Prostatic Neoplasm; Urinary Bladder Neoplasm

• Registration Number: NCT02966535
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Gas exchange disturbance frequently occurs in steep Trendelenburg position during robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic pressure and absorbed carbon dioxide (CO2) gas insufflated into abdominal cavity, hypercapnia as well as hypoxia may occur. Inverse ratio ventilation or prolonged inspiratory time during mechanical ventilation has been reported to be improve gas exchange in adult respiratory distress syndrome. The investigators attempt to test the hypothesis that prolonged inspiratory time may improve the gas exchange during robot-assisted laparoscopic urologic surgery.

Detailed Description

Gas exchange disturbance frequently occurs in steep Trendelenburg position during robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic pressure and absorbed CO2 gas insufflated into abdominal cavity, hypercapnia as well as hypoxia may occur. Inverse ratio ventilation or prolonged inspiratory time during mechanical ventilation has been reported to be improve gas exchange in adult respiratory distress syndrome. The investigators attempt to test the hypothesis that prolonged inspiratory time (I:E ratio = 1:1) may improve the gas exchange during robot-assisted laparoscopic urologic surgery.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-13
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-17
• Primary Completion: 2017-02
• Study Completion: 2017-04
• Status Verified: 2017-09
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

• American Society of Anesthesiologists physical status class I-II and scheduled for an elective robot-assisted laparoscopic radical prostatectomy or robot-assisted laparoscopic radical cystectomy
• Patients who voluntarily decides to participate in the trial and has agreed in written informed consent

Exclusion Criteria

• Patients with the anatomical abnormalities of respiratory system(abnormal airway anatomy, severe scoliosis, post-pneumonectomy state), severe chronic respiratory diseases, chronic obstructive pulmonary disease (COPD), asthma, heart failure, obesity ( Body Mass Index [BMI] > 30kg/m2), severe hepatic failure or renal failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
PaCO2 (mmHg) in the patient's arterial blood gas analysis	60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning	PaCO2 (arterial partial pressure of carbon dioxide)

Secondary Outcome Measures

Name	Time	Method
Alveolar-arterial oxygen difference	120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
PaO2 (mmHg) in the patient's arterial blood gas analysis	10 min after restoration of supine position	PaO2 (arterial partial pressure of oxygen)
oxygen index	120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning	oxygen index calculated by PaO2/inspired oxygen fraction
PaCO2 (mmHg) in the patient's arterial blood gas analysis	10 min after restoration of supine position	PaCO2 (arterial partial pressure of carbon dioxide)
Respiratory compliance (Static, Dynamic)	120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning	Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of