Clinical trial NCT03435913: Transpulmonary Driving Pressure and Intra-abdominal Pressure Relationship During Laparoscopic Surgery
Official title: Assessment of Transpulmonary Driving Pressure and Intra-abdominal Pressure Relationship at Different Levels of Positive End-expiratory Pressure (PEEP) During Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, General/Methods
Laparoscopy
Respiration, Artificial
Positive-Pressure Respiration
End-Expiratory Pressure, Positive
Ventilator-Induced Lung Injury
Keywords: Mechanical ventilation
Driving Pressure
Protective Lung VEntilation
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Transpulmonary driving pressure (TpDp) difference between standard and matched PEEP ventilation
timeFrame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)
Secondary outcomes:
measure: Transpulmonary driving pressure and intra-abdmominal pressure relationship (multivariate adaptive linear regression)
timeFrame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)
measure: Transpulmonary driving pressure and respiratory driving pressure (RDp) relationship (multivariate adaptive linear regression).
timeFrame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)
measure: Respiratory system compliance (Crs) difference between standard and matched PEEP levels
timeFrame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)
measure: Pulmonary compliance (Cp) difference
timeFrame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)
measure: Chest wall compliance (CCw) difference
timeFrame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)
measure: Pulmonary Stress index difference
timeFrame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
Study officials:
References:
citation: Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4.
citation: Cortes-Puentes GA, Gard KE, Adams AB, Faltesek KA, Anderson CP, Dries DJ, Marini JJ. Value and limitations of transpulmonary pressure calculations during intra-abdominal hypertension. Crit Care Med. 2013 Aug;41(8):1870-7. doi: 10.1097/CCM.0b013e31828a3bea.
citation: Cinnella G, Grasso S, Spadaro S, Rauseo M, Mirabella L, Salatto P, De Capraris A, Nappi L, Greco P, Dambrosio M. Effects of recruitment maneuver and positive end-expiratory pressure on respiratory mechanics and transpulmonary pressure during laparoscopic surgery. Anesthesiology. 2013 Jan;118(1):114-22. doi: 10.1097/ALN.0b013e3182746a10.
citation: D'Antini D, Rauseo M, Grasso S, Mirabella L, Camporota L, Cotoia A, Spadaro S, Fersini A, Petta R, Menga R, Sciusco A, Dambrosio M, Cinnella G. Physiological effects of the open lung approach during laparoscopic cholecystectomy: focus on driving pressure. Minerva Anestesiol. 2018 Feb;84(2):159-167. doi: 10.23736/S0375-9393.17.12042-0. Epub 2017 Jul 5.