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

Primary Purpose

Prostatic Neoplasm, Urinary Bladder Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
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)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasm

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1:2, 1:1 group

1:1, 1:2 group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

PaCO2 (mmHg) in the patient's arterial blood gas analysis
PaCO2 (arterial partial pressure of carbon dioxide)

Secondary Outcome Measures

PaCO2 (mmHg) in the patient's arterial blood gas analysis
PaCO2 (arterial partial pressure of carbon dioxide)
PaO2 (mmHg) in the patient's arterial blood gas analysis
PaO2 (arterial partial pressure of oxygen)
PaO2 (mmHg) in the patient's arterial blood gas analysis
PaO2 (arterial partial pressure of oxygen)
PaCO2 (mmHg) in the patient's arterial blood gas analysis
PaCO2 (arterial partial pressure of carbon dioxide)
PaO2 (mmHg) in the patient's arterial blood gas analysis
PaO2 (arterial partial pressure of oxygen)
PaCO2 (mmHg) in the patient's arterial blood gas analysis
PaCO2 (arterial partial pressure of carbon dioxide)
PaO2 (mmHg) in the patient's arterial blood gas analysis
PaO2 (arterial partial pressure of oxygen)
Respiratory compliance (Static, Dynamic)
Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)
Respiratory compliance (Static, Dynamic)
Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)
Respiratory compliance (Static, Dynamic)
Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)
oxygen index
oxygen index calculated by PaO2/inspired oxygen fraction
oxygen index
oxygen index calculated by PaO2/inspired oxygen fraction
oxygen index
oxygen index calculated by PaO2/inspired oxygen fraction
Alveolar-arterial oxygen difference
Alveolar-arterial oxygen difference
Alveolar-arterial oxygen difference

Full Information

First Posted
November 13, 2016
Last Updated
March 12, 2019
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02966535
Brief Title
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm, Urinary Bladder Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1:2, 1:1 group
Arm Type
Experimental
Arm Description
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.
Arm Title
1:1, 1:2 group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1)
Intervention Description
Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1)
Intervention Type
Device
Intervention Name(s)
Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)
Intervention Description
Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)
Primary Outcome Measure Information:
Title
PaCO2 (mmHg) in the patient's arterial blood gas analysis
Description
PaCO2 (arterial partial pressure of carbon dioxide)
Time Frame
60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
Secondary Outcome Measure Information:
Title
PaCO2 (mmHg) in the patient's arterial blood gas analysis
Description
PaCO2 (arterial partial pressure of carbon dioxide)
Time Frame
5 minutes after anesthesia induction
Title
PaO2 (mmHg) in the patient's arterial blood gas analysis
Description
PaO2 (arterial partial pressure of oxygen)
Time Frame
5 minutes after anesthesia induction
Title
PaO2 (mmHg) in the patient's arterial blood gas analysis
Description
PaO2 (arterial partial pressure of oxygen)
Time Frame
60 minutes after anesthesia induction
Title
PaCO2 (mmHg) in the patient's arterial blood gas analysis
Description
PaCO2 (arterial partial pressure of carbon dioxide)
Time Frame
120 minutes after anesthesia induction
Title
PaO2 (mmHg) in the patient's arterial blood gas analysis
Description
PaO2 (arterial partial pressure of oxygen)
Time Frame
120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
Title
PaCO2 (mmHg) in the patient's arterial blood gas analysis
Description
PaCO2 (arterial partial pressure of carbon dioxide)
Time Frame
10 min after restoration of supine position
Title
PaO2 (mmHg) in the patient's arterial blood gas analysis
Description
PaO2 (arterial partial pressure of oxygen)
Time Frame
10 min after restoration of supine position
Title
Respiratory compliance (Static, Dynamic)
Description
Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)
Time Frame
5 minutes after anesthesia induction
Title
Respiratory compliance (Static, Dynamic)
Description
Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)
Time Frame
60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
Title
Respiratory compliance (Static, Dynamic)
Description
Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)
Time Frame
120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
Title
oxygen index
Description
oxygen index calculated by PaO2/inspired oxygen fraction
Time Frame
5 minutes after anesthesia induction
Title
oxygen index
Description
oxygen index calculated by PaO2/inspired oxygen fraction
Time Frame
60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
Title
oxygen index
Description
oxygen index calculated by PaO2/inspired oxygen fraction
Time Frame
120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
Title
Alveolar-arterial oxygen difference
Time Frame
5 minutes after anesthesia induction
Title
Alveolar-arterial oxygen difference
Time Frame
60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
Title
Alveolar-arterial oxygen difference
Time Frame
120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25277444
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.
Results Reference
background
PubMed Identifier
22415437
Citation
Gainsburg DM. Anesthetic concerns for robotic-assisted laparoscopic radical prostatectomy. Minerva Anestesiol. 2012 May;78(5):596-604. Epub 2012 Mar 13.
Results Reference
background
PubMed Identifier
25869025
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.
Results Reference
background

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

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