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

NCT ID: NCT02966535

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-04-30

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.

Conditions

Prostatic Neoplasm; Urinary Bladder Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

Interventions

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)

Intervention Type: DEVICE

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)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Won Ho Kim, MD

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 25277444 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 22415437 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25869025 (View on PubMed)

Other Identifiers

1609-102-793

Identifier Type: -

Identifier Source: org_study_id