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

March 12, 2019 updated by: Won Ho Kim, MD, Seoul National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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: 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)
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: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PaCO2 (mmHg) in the patient's arterial blood gas analysis
Time Frame: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
PaCO2 (arterial partial pressure of carbon dioxide)
60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

November 13, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (Estimate)

November 17, 2016

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1609-102-793

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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