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NCT02966535 Clinical Trial

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

Prostatic Neoplasm 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02966535
Other study ID # 1609-102-793
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date April 2017

Study information
Verified date September 2017
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date April 2017
Est. primary completion date February 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 90 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1)
Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1)
• Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)
Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. Review. — View Citation

Gainsburg DM. Anesthetic concerns for robotic-assisted laparoscopic radical prostatectomy. Minerva Anestesiol. 2012 May;78(5):596-604. Epub 2012 Mar 13. Review. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary PaCO2 (mmHg) in the patient's arterial blood gas analysis PaCO2 (arterial partial pressure of carbon dioxide) 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
Secondary PaCO2 (mmHg) in the patient's arterial blood gas analysis PaCO2 (arterial partial pressure of carbon dioxide) 5 minutes after anesthesia induction
Secondary PaO2 (mmHg) in the patient's arterial blood gas analysis PaO2 (arterial partial pressure of oxygen) 5 minutes after anesthesia induction
Secondary PaO2 (mmHg) in the patient's arterial blood gas analysis PaO2 (arterial partial pressure of oxygen) 60 minutes after anesthesia induction
Secondary PaCO2 (mmHg) in the patient's arterial blood gas analysis PaCO2 (arterial partial pressure of carbon dioxide) 120 minutes after anesthesia induction
Secondary PaO2 (mmHg) in the patient's arterial blood gas analysis PaO2 (arterial partial pressure of oxygen) 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
Secondary PaCO2 (mmHg) in the patient's arterial blood gas analysis PaCO2 (arterial partial pressure of carbon dioxide) 10 min after restoration of supine position
Secondary PaO2 (mmHg) in the patient's arterial blood gas analysis PaO2 (arterial partial pressure of oxygen) 10 min after restoration of supine position
Secondary Respiratory compliance (Static, Dynamic) Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP) 5 minutes after anesthesia induction
Secondary Respiratory compliance (Static, Dynamic) Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP) 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
Secondary Respiratory compliance (Static, Dynamic) Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP) 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
Secondary oxygen index oxygen index calculated by PaO2/inspired oxygen fraction 5 minutes after anesthesia induction
Secondary oxygen index oxygen index calculated by PaO2/inspired oxygen fraction 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
Secondary oxygen index oxygen index calculated by PaO2/inspired oxygen fraction 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
Secondary Alveolar-arterial oxygen difference 5 minutes after anesthesia induction
Secondary Alveolar-arterial oxygen difference 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
Secondary Alveolar-arterial oxygen difference 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
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