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NCT Number: NCT02966535

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2016
Registry last updated
Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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