Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05155371 |
| Other study ID # |
PEEP Titration of RALP |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 20, 2021 |
| Est. completion date |
January 20, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Fudan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Optimal intraoperative positive end expiratory pressure (PEEP) improves the outcome. Optimal
PEEP is not only very different among individuals, but each individual's optimal PEEP is
affected by positioning, muscle paralysis, and several other factors. Several techniques have
been used to determine the optimal PEEP. For example, electrical impedance tomography(EIT)can
be performed at the bedside.However, the application of this technique requires special
training, increases the workload of the care team, and the cost-efficiencyof this procedure
remains to be determined.We hypothesized that optimal PEEP could be obtained by titration of
intraoperative PEEP levels and FiO2with SpO2 guidance. Our secondary hypothesis was that
maintenance of intraoperative optimal PEEP derived via this method improves intraoperative
oxygenation and reduces the incidence of postoperative hypoxemia.We tested our hypothesis in
patients undergoing robotic-assisted laparoscopic prostatectomy.
Description:
Lung-protective ventilation strategies are recommended for patients under mechanical
ventilation with intermediate-risk and high-risk in order to minimize lung injury and
respiratory complications of critically ill patients associated with mechanical ventilation ,
such as atelectasis and pneumonia. Low tidal volume (TV) had been proven protective .
However, there is no consensus on what the optimal positive end expiatory pressure (PEEP) is
for patients with healthy lungs undergoing general anesthesia, particularly for those who are
undergoing abdominal surgery. A recent study showed that electrical impedance tomography
(EIT) could be used to identify optimal PEEP, where both lungs collapse, hyper-insufflation
is minimized, and the variation of optimal PEEP in patients with healthy lungs undergoing
abdominal surgery is profound.Therefore, a fixed PEEP applied to all patients surely
over-PEEP some and under-PEEP others. This study also demonstrates that maintaining the
optimal PEEP intra-operatively not only improves intra-operative oxygenation but also reduces
the incidence and severity of atelectasis post-operatively . Even though this study focuses
on the improvement of physiology rather than the outcome, the benefit of intra-operative
optimal PEEP is sustained for at least for one-hour post extubation. Therefore, optimized
intra-operative PEEP could potentially have a positive impact onoutcomes. However, the
cost-effectiveness of EIT used intraoperatively as routine practice still needs to be
determined. Development of new methods which can be used intraoperatively and
arecost-effective and user-friendly is an unmet demand.
Recently, Ferrando et al conducted a study in which the authors used minimal FiO2 to maintain
clinically acceptable arterial blood O2 saturation by titrating PEEP. Even though this study
was not randomized and sample size was insufficient to demonstrate improved outcomes, it
clearly demonstrated its feasibility and safety. We hypothesize that titration of
intraoperative PEEP using minimal FiO2 while maintaining clinically acceptable O2 saturation
allows clinicians to identify the optimal PEEP. We will test this hypothesis on patients
undegoing RALP. We chose this population because these patients have increased number of
postoperative complications . Additionally, physicians are prone to using suboptimal
ventilation strategies such as inappropriate tidal volumes and intraoperative PEEP in this
population; therefore these patients are more likely to achieve maximal benefit with
optimized intra-operative PEEP.
