Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 66 of 667 for:    CARBON DIOXIDE AND arterial

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02966535
Recruitment Status : Completed
First Posted : November 17, 2016
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Won Ho Kim, MD, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasm Urinary Bladder Neoplasm Device: Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1) Device: Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. PaCO2 (mmHg) in the patient's arterial blood gas analysis [ Time Frame: 5 minutes after anesthesia induction ]
    PaCO2 (arterial partial pressure of carbon dioxide)

  2. PaO2 (mmHg) in the patient's arterial blood gas analysis [ Time Frame: 5 minutes after anesthesia induction ]
    PaO2 (arterial partial pressure of oxygen)

  3. PaO2 (mmHg) in the patient's arterial blood gas analysis [ Time Frame: 60 minutes after anesthesia induction ]
    PaO2 (arterial partial pressure of oxygen)

  4. PaCO2 (mmHg) in the patient's arterial blood gas analysis [ Time Frame: 120 minutes after anesthesia induction ]
    PaCO2 (arterial partial pressure of carbon dioxide)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. oxygen index [ Time Frame: 5 minutes after anesthesia induction ]
    oxygen index calculated by PaO2/inspired oxygen fraction

  12. oxygen index [ Time Frame: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning ]
    oxygen index calculated by PaO2/inspired oxygen fraction

  13. oxygen index [ Time Frame: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning ]
    oxygen index calculated by PaO2/inspired oxygen fraction

  14. Alveolar-arterial oxygen difference [ Time Frame: 5 minutes after anesthesia induction ]
  15. Alveolar-arterial oxygen difference [ Time Frame: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning ]
  16. Alveolar-arterial oxygen difference [ Time Frame: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966535


Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital

Publications:
Layout table for additonal information
Responsible Party: Won Ho Kim, MD, Clinical Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02966535     History of Changes
Other Study ID Numbers: 1609-102-793
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Urinary Bladder Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Urologic Neoplasms
Urinary Bladder Diseases
Urologic Diseases