The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial
Keywords
Abstract
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.
Dates
| Last Verified: | 08/31/2017 |
| First Submitted: | 11/12/2016 |
| Estimated Enrollment Submitted: | 11/14/2016 |
| First Posted: | 11/16/2016 |
| Last Update Submitted: | 03/11/2019 |
| Last Update Posted: | 03/13/2019 |
| Actual Study Start Date: | 10/31/2016 |
| Estimated Primary Completion Date: | 01/31/2017 |
| Estimated Study Completion Date: | 03/31/2017 |
Condition or disease
Intervention/treatment
Device: 1:2, 1:1 group
Device: 1:1, 1:2 group
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1:2, 1:1 group Inspiratory to expiratory time ratio (I:E ratio) of 1:2 during the first one hour of laparoscopy and then switched to I:E ratio of 1:1 during the rest time of laparoscopy. | Device: 1:2, 1:1 group Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1) |
| Active Comparator: 1:1, 1:2 group Inspiratory to expiratory time ratio (I:E ratio) of 1:1 during the first one hour of laparoscopy and then switched to I:E ratio of 1:2 during the rest time of laparoscopy. | Device: 1:1, 1:2 group Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2) |
Eligibility Criteria
| Ages Eligible for Study | 20 Years To 20 Years |
| Sexes Eligible for Study | Male |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. PaCO2 (mmHg) in the patient's arterial blood gas analysis [60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning]
Secondary Outcome Measures
1. PaCO2 (mmHg) in the patient's arterial blood gas analysis [5 minutes after anesthesia induction]
2. PaO2 (mmHg) in the patient's arterial blood gas analysis [5 minutes after anesthesia induction]
3. PaO2 (mmHg) in the patient's arterial blood gas analysis [60 minutes after anesthesia induction]
4. PaCO2 (mmHg) in the patient's arterial blood gas analysis [120 minutes after anesthesia induction]
5. PaO2 (mmHg) in the patient's arterial blood gas analysis [120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning]
6. PaCO2 (mmHg) in the patient's arterial blood gas analysis [10 min after restoration of supine position]
7. PaO2 (mmHg) in the patient's arterial blood gas analysis [10 min after restoration of supine position]
8. Respiratory compliance (Static, Dynamic) [5 minutes after anesthesia induction]
9. Respiratory compliance (Static, Dynamic) [60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning]
10. Respiratory compliance (Static, Dynamic) [120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning]
11. oxygen index [5 minutes after anesthesia induction]
12. oxygen index [60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning]
13. oxygen index [120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning]
14. Alveolar-arterial oxygen difference [5 minutes after anesthesia induction]
15. Alveolar-arterial oxygen difference [60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning]
16. Alveolar-arterial oxygen difference [120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning]
