Clinical trial NCT05702554: Recruitment-to-inflation Ratio to Set Positive End-expiratory Pressure for Laparoscopic/Robotic Surgery: a Multicenter Study
Official title: Recruitment-to-inflation Ratio to Set Positive End-expiratory Pressure for Laparoscopic/Robotic Surgery: a Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory System Mechanics
Pneumoperitoneum
Lead sponsor: Azienda Ospedaliera di Perugia
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult obese (body mass index ≥ 30 kg/m2) patients undergoing invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum

Brief 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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Will be excluded all the patients with the following conditions: american society of anesthesiologists (ASA) score ≥ 4; severe cardiopathy, intracranial hypertension, tracheosthomy, previous cardio-thoracic surgery, pulmonary hypertrension, broncho-pleural fistula, pulmonary emphysema, pnumothorax, chronic respiratory failure, chronic obstructive pulmonary disease, pregnancy.

Primary outcomes:
measure: Intraoperative respiratory system mechanics
timeFrame: 1 hour following PEEP application
Secondary outcomes:
measure: respiratory pulmonary complications incidence
timeFrame: up to 7 days after surgery
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Università degli Studi di Perugia
state: Umbria, Italy
city: Perugia
country: Italy
facility: Università degli Studi di Perugia
Study officials:
References: