Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06247943 |
| Other study ID # |
GWang026 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2024 |
| Est. completion date |
March 17, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Tianjin Medical University General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Obesity is becoming a common condition and bariatric metabolic surgery is one of the main
options for treating morbid obesity. However, since most patients undergoing robotic
bariatric surgery are class III obese, it brings new challenges to perioperative anesthesia
management. Here, we explored the effects of lung-protective ventilation strategies on
pulmonary oxygenation function and respiratory mechanics in patients undergoing robotic
bariatric surgery.
Description:
Forty obese patients who underwent robotic bariatric surgery in our hospital were selected
and randomly divided into a lung-protective ventilation strategy group (Group P) and a
control group (Group C). The volume-controlled mode was used to assist ventilation, and the
inspiratory/expiratory ratio (I: E) was 1:2. Tidal volume (VT) was set according to the
Predicted body weight (PBW) throughout the whole procedure, and in group C, VT was 9 ml /kg
without Positive end-expiratory pressure (PEEP), and the inhaled oxygen concentration
(Fraction of oxygen) was 0.5 ml /kg, while the inspiratory oxygen concentration (Fraction of
oxygen) was 0.5 ml /kg. Group C: VT 9ml /kg, no Positive end-expiratory pressure (PEEP),
Fraction of inspiration O2 (FiO2) of 60%; Group P: the ventilation mode was the same as that
of Group C from tracheal intubation to the beginning of pneumoperitoneum for 10 minutes, and
after 10 minutes of pneumoperitoneum, the ventilation mode was the same as that of Group C.
After the pneumoperitoneum for 10 minutes, the ventilation mode was VT 7ml/kg, PEEP 6cmH2O,
FiO2 of 40%, and the plateau pressure was maintained at <30cmH2O. In both groups, the
intraoperative gas flow was 2L/min, and SpO2 was maintained at ≥95%; if it could not be
maintained, the oxygenation function of the patients could be improved by adjusting the
ventilation parameters and strategies; meanwhile, the respiratory rate (RR) was adjusted to
maintain the End-tidal carbon dioxide partial pressure (PETCO2) at ≥30%, and the end-tidal
carbon dioxide partial pressure (PETCO2) was maintained at ≥30%, and the end-tidal carbon
dioxide partial pressure (PETCO2) was maintained at ≥30%. The respiratory mechanical
parameters: tidal volume, RR, airway peak pressure (PPeak), plateau pressure (PPeak), and
plateau pressure (PPeak) were recorded at 5 minutes after tracheal intubation (T0), 10
minutes after the start of the pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and
10 minutes after the pneumoperitoneum was closed (T4). pressure (PPeak), and plateau pressure
(PPlate), and calculate the dynamic lung compliance; arterial blood was drawn at T0, T1, T2,
T3, and T4, respectively, and the arterial partial pressure of oxygen (PaO2) and the arterial
partial pressure of carbon dioxide (Arterial CO2) were measured. The arterial partial
pressure of oxygen (PaO2) and arterial carbon dioxide pressure (PaCO2) were measured, and the
oxygenation index (OI) was calculated.
