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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02966535
Enrollment
32
Registered
2016-11-17
Start date
2016-11-30
Completion date
2017-04-30
Last updated
2019-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasm, Urinary Bladder Neoplasm

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.

Interventions

DEVICEAdjustment 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)

DEVICEAdjustment 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)

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
20 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
PaCO2 (mmHg) in the patient's arterial blood gas analysis60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioningPaCO2 (arterial partial pressure of carbon dioxide)

Secondary

MeasureTime frameDescription
PaCO2 (mmHg) in the patient's arterial blood gas analysis5 minutes after anesthesia inductionPaCO2 (arterial partial pressure of carbon dioxide)
PaO2 (mmHg) in the patient's arterial blood gas analysis5 minutes after anesthesia inductionPaO2 (arterial partial pressure of oxygen)
Respiratory compliance (Static, Dynamic)5 minutes after anesthesia inductionStatic compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)
oxygen index5 minutes after anesthesia inductionoxygen index calculated by PaO2/inspired oxygen fraction
Alveolar-arterial oxygen difference5 minutes after anesthesia induction

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026