Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05702554 |
| Other study ID # |
PEEP_LAP1 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 5, 2023 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Azienda Ospedaliera di Perugia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The present investigation is focused to assess the effects of positive end-expiratory
pressure (PEEP) on respiratory system compliance in obese patients invasive mechanical
ventilation for laparoscopic or robotic surgery with pneumoperitoneum
Description:
Adult obese (body mass index ≥ 30 kg/m2) patients undergoing invasive mechanical ventilation
for laparoscopic or robotic surgery with pneumoperitoneum will be enrolled, upon the
acquisition of informed consent.
Will be excluded all the patients with the following conditions: American society of
anesthesiologists (ASA) score ≥ 4; severe cardiopathy, intracranial hypertension,
tracheostomy, previous cardio-thoracic surgery, pulmonary hypertension, broncho-pleural
fistula, pulmonary emphysema, pneumothorax, chronic respiratory failure, chronic obstructive
pulmonary disease, pregnancy.
Thereafter, general anesthesia will be induced, according to current clinical practice and
mechanical ventilation will be commenced according to current recommendations.
Following the application of definitive pneumoeritoneum and body position, the
recruitment/inflation procedure will be carried out to identify PEEP. PEEP-induced
recruitment will be computed with high PEEP set at 15 cmh2o (or higher) and low PEEP set at 5
cmh2o. In case of an airway opening pressure > 5 cmh2o, the airway opening pressure (AOP)
will be set as low PEEP and the high PEEP will be set at the value corresponding to AOP+ 10
cmh20. During the procedure, tidal volume will be maintained between 6-8 ml/kg of predicted
body weight. On the basis of the recruitment-to-inflation ratio (R/I), PEEP will be set as
follows: low PEEP, in presence of R/I < 0,5; high PEEP with R/I ≥ 1.5; PEEP set within low
and high PEEP range on clinical decision, if R/I ≥ 0.5 and <1.5.
After 20 min from the onset of mechanical ventilation and 1 hour from PEEP application
following pneumoperitoneum and definitive body position, mechanics of the respiratory system
for compliance and driving pressure will be assessed.
As an optional evaluation, a lung ultrasound examination will be performed before general
anesthesia induction and 1 hour after extubation, before discharging the patient from
recovery room.
During anesthesia vital signs will be continuously monitored. On the clinically judgement,
arterial blood gases will be carried out across the study stages.
