Clinical trial NCT02966535: The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial
Official title: The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasm
Urinary Bladder Neoplasm
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PaCO2 (mmHg) in the patient's arterial blood gas analysis
timeFrame: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
Secondary outcomes:
measure: PaCO2 (mmHg) in the patient's arterial blood gas analysis
timeFrame: 5 minutes after anesthesia induction
measure: PaO2 (mmHg) in the patient's arterial blood gas analysis
timeFrame: 5 minutes after anesthesia induction
measure: PaO2 (mmHg) in the patient's arterial blood gas analysis
timeFrame: 60 minutes after anesthesia induction
measure: PaCO2 (mmHg) in the patient's arterial blood gas analysis
timeFrame: 120 minutes after anesthesia induction
measure: PaO2 (mmHg) in the patient's arterial blood gas analysis
timeFrame: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
measure: PaCO2 (mmHg) in the patient's arterial blood gas analysis
timeFrame: 10 min after restoration of supine position
measure: PaO2 (mmHg) in the patient's arterial blood gas analysis
timeFrame: 10 min after restoration of supine position
measure: Respiratory compliance (Static, Dynamic)
timeFrame: 5 minutes after anesthesia induction
measure: Respiratory compliance (Static, Dynamic)
timeFrame: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
measure: Respiratory compliance (Static, Dynamic)
timeFrame: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
measure: oxygen index
timeFrame: 5 minutes after anesthesia induction
measure: oxygen index
timeFrame: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
measure: oxygen index
timeFrame: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
measure: Alveolar-arterial oxygen difference
timeFrame: 5 minutes after anesthesia induction
measure: Alveolar-arterial oxygen difference
timeFrame: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
measure: Alveolar-arterial oxygen difference
timeFrame: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: De Carlo F, Celestino F, Verri C, Masedu F, Liberati E, Di Stasi SM. Retropubic, laparoscopic, and robot-assisted radical prostatectomy: surgical, oncological, and functional outcomes: a systematic review. Urol Int. 2014;93(4):373-83. doi: 10.1159/000366008. Epub 2014 Sep 23.
citation: Gainsburg DM. Anesthetic concerns for robotic-assisted laparoscopic radical prostatectomy. Minerva Anestesiol. 2012 May;78(5):596-604. Epub 2012 Mar 13.
citation: Kim MS, Kim NY, Lee KY, Choi YD, Hong JH, Bai SJ. The impact of two different inspiratory to expiratory ratios (1:1 and 1:2) on respiratory mechanics and oxygenation during volume-controlled ventilation in robot-assisted laparoscopic radical prostatectomy: a randomized controlled trial. Can J Anaesth. 2015 Sep;62(9):979-87. doi: 10.1007/s12630-015-0383-2. Epub 2015 Apr 14.