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

Seoul National University Hospital32 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Prostatic Neoplasm Urinary Bladder Neoplasm

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)

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)

Eligibility

Sex: MALEMin age: 20 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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

PaCO2 (arterial partial pressure of carbon dioxide)

Time frame: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning

Secondary Outcomes

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

PaCO2 (arterial partial pressure of carbon dioxide)

Time frame: 5 minutes after anesthesia induction

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

PaO2 (arterial partial pressure of oxygen)

Time frame: 5 minutes after anesthesia induction

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

PaO2 (arterial partial pressure of oxygen)

Time frame: 60 minutes after anesthesia induction

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

PaCO2 (arterial partial pressure of carbon dioxide)

Time frame: 120 minutes after anesthesia induction

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

PaO2 (arterial partial pressure of oxygen)

Time frame: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning

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

PaCO2 (arterial partial pressure of carbon dioxide)

Time frame: 10 min after restoration of supine position

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

PaO2 (arterial partial pressure of oxygen)

Time frame: 10 min after restoration of supine position

Respiratory compliance (Static, Dynamic)

Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)

Time frame: 5 minutes after anesthesia induction

Respiratory compliance (Static, Dynamic)

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

Respiratory compliance (Static, Dynamic)

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

oxygen index

oxygen index calculated by PaO2/inspired oxygen fraction

Time frame: 5 minutes after anesthesia induction

oxygen index

oxygen index calculated by PaO2/inspired oxygen fraction

Time frame: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning

oxygen index

oxygen index calculated by PaO2/inspired oxygen fraction

Time frame: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning

Alveolar-arterial oxygen difference

Time frame: 5 minutes after anesthesia induction

Alveolar-arterial oxygen difference

Time frame: 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

Data from ClinicalTrials.gov

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