Anesthesia, General/Methods, End-Expiratory Pressure, Positive, Laparoscopy, Positive-Pressure Respiration, Respiration, Artificial, Ventilator-Induced Lung Injury
Conditions
Keywords
Mechanical ventilation, Driving Pressure, Protective Lung VEntilation
Brief summary
Objective: The aim of this project is to evaluate how intra-abdominal pressure paired coupled with different ventilatory positive end-expiratory pressure levels affects the transpulmonary driving pressure during pneumoperiteneum insufflation for laparoscopic surgery. Methodology: Patients undergoing laparoscopic surgery will be included. The study will investigate the relationship between intra-abdominal pressure (IAP) and transpulmonary driving pressure (TpDp) and the effect of titration of PEEP on their relationship. At three different levels of intra-abdominal pressure, the respiratory driving pressure (RDp) and TpDp in each subject will be measured in each subject. The same subject will undergo two different ventilation strategies. Demographic data (height, weight, body mass index and sex), ASA physical status (surgical risk classification of the American Society of Anesthesiology), number of previous abdominal surgeries, number of previous pregnancies, and respiratory comorbidities will be collected. Respiratory pressures and mechanics will be recorded at each level of intra-abdominal pressure (IAP) during each ventilatory strategy. The variables recorded will include: airway pressures (Plateau pressure Pplat, Peak pressure, Ppeak), the final esophageal pressure of inspiration and expiration and pulmonary stress index. Mixed linear regression will be used to evaluate the relationship between different PEEP levels, IAP and TpDp by adjusting for known confounders and adding individuals as a random factor. Likewise, an analysis using a mixed linear regression model with the pulmonary stress index as a function of the intra-abdominal pressure, the ventilation regime, and a specific random intercept term for each subject will be performed.
Interventions
During mechanical ventilation a fixed PEEP (5 mcH2O) is set at all IAP levels during pneumoperitoneum insufflation
OTHERMatched PEEP ventilation
During mechanical ventilation PEEP is matched to IAP level
Sponsors
Hospital Universitario La Fe
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiology (ASA) risk scale I to III * Age \> 18 years * Previously signed informed consent * Undergoing laparoscopic surgery
Exclusion criteria
* ASA ≥ IV * Pregnancy * Advanced liver, kidney or cardiopulmonary disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transpulmonary driving pressure (TpDp) difference between standard and matched PEEP ventilation | Pneumoperitoneum insufflation before surgery (up to 30 minutes) | TpDp (assessed in centimeters of water, cmH20) as assessed by ventilatory pressure and pleural pressure (recorded by an esophageal probe) is recorded at every intra-abdominal pressure level during pneumoperitoneum insufflation. The primary outcome is the difference between a standard perioperative management (fixed PEEP + 15 mmHg pneumoperitoneum pressure) and matched PEEP to intra-abdominal pressure and 8mmHg intra-abdominal pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transpulmonary driving pressure and respiratory driving pressure (RDp) relationship (multivariate adaptive linear regression). | Pneumoperitoneum insufflation before surgery (up to 30 minutes) | Respiratory driving pressure (transpulmonary driving pressure + pressure to move the chest wall, in cmH20, RpDp) and TpDp relationship at each IAP and PEEP level will be assessed. The relationship between TpDp and RpDp (both treated as continuous variables) at each PEEP level is plotted and a multiadaptive linear regression is fitted. |
| Respiratory system compliance (Crs) difference between standard and matched PEEP levels | Pneumoperitoneum insufflation before surgery (up to 30 minutes) | Respiratory system compliance measures the system's ability to stretch. It has two components Lung and Chest Wall (measured in milliliter/centimeters of water, ml/cmH20) |
| Transpulmonary driving pressure and intra-abdmominal pressure relationship (multivariate adaptive linear regression) | Pneumoperitoneum insufflation before surgery (up to 30 minutes) | TpDp (in cmH20) is recorded at different levels of IAP and with two different PEEP settings (in cmH20; two levels are: fixed at each IAP level, standard group and matched at each IAP level, matched group). The relationship between TpDp and IAP (both treated as continuous variables) at each PEEP level is plotted and a multiadaptive linear regression is fitted. |
| Chest wall compliance (CCw) difference | Pneumoperitoneum insufflation before surgery (up to 30 minutes) | Respiratory system compliance measures the system's ability to stretch (ml/cmH20). It has two components Lung and Chest Wall (measured in milliliter/centimeters of water, ml/cmH20). By using an esophageal probe measurement the two can be partitioned and analyzed separately. |
| Pulmonary Stress index difference | Pneumoperitoneum insufflation before surgery (up to 30 minutes) | Stress index is based on respiratory pressure curve analysis and assess whether the lungs are overdistended or collapsed |
| Pulmonary compliance (Cp) difference | Pneumoperitoneum insufflation before surgery (up to 30 minutes) | Respiratory system compliance measures the system's ability to stretch (ml/cmH20). It has two components Lung and Chest Wall (measured in milliliter/centimeters of water, ml/cmH20). By using an esophageal probe measurement the two can be partitioned and analyzed separately. |
Countries
Spain
Outcome results
None listed