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

NCT02966535 | Completed

• 1 other identifier: 1609-102-793
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasm; Urinary Bladder Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• PaCO2 (mmHg) in the patient's arterial blood gas analysis

  5 minutes after anesthesia induction

• PaO2 (mmHg) in the patient's arterial blood gas analysis

  5 minutes after anesthesia induction

• PaO2 (mmHg) in the patient's arterial blood gas analysis

  60 minutes after anesthesia induction

• PaCO2 (mmHg) in the patient's arterial blood gas analysis

  120 minutes after anesthesia induction

• PaO2 (mmHg) in the patient's arterial blood gas analysis

  120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning

Study Arms (2)

1:2, 1:1 group

EXPERIMENTAL

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

1:1, 1:2 group

ACTIVE COMPARATOR

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: 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) DEVICE

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

1:2, 1:1 group

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

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

1:1, 1:2 group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related 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.

  PMID: 25277444 BACKGROUND

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

  PMID: 22415437 BACKGROUND

• 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.

  PMID: 25869025 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: November 13, 2016
• First Posted: November 17, 2016
• Study Start: November 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: April 1, 2017
• Last Updated: March 14, 2019

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)