NCT03435913

Transpulmonary Driving Pressure and Intra-abdominal Pressure Relationship During Laparoscopic Surgery

Completed NA Last updated 17 December 2019

What this trial tests

NA trial testing Standard PEEP ventilation in Anesthesia, General/Methods in 30 participants. Completed in 21 November 2018.

Timeline

19 April 2018

Primary endpoint
21 November 2018

21 November 2018

Quick facts

Lead sponsor	Hospital Universitario La Fe
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	30
Start date	19 April 2018
Primary completion	21 November 2018
Estimated completion	21 November 2018
Sites	1 location across Spain

Drugs / interventions tested

• Standard PEEP ventilation
• Matched PEEP ventilation

Conditions studied

• Anesthesia, General/Methods — all drugs for Anesthesia, General/Methods →
• Laparoscopy — all drugs for Laparoscopy →
• Respiration, Artificial — all drugs for Respiration, Artificial →
• Positive-Pressure Respiration — all drugs for Positive-Pressure Respiration →

Sponsor

Hospital Universitario La Fe

Who can join

18 and older, any sex, with Anesthesia, General/Methods or Laparoscopy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. An Individualized Low-Pneumoperitoneum-Pressure Strategy May Prevent a Reduction in Liver Perfusion during Colorectal Laparoscopic Surgery.
   Olmedilla Arnal LE, Cambronero OD, Mazzinari G, Pérez Peña JM, et al · · 2023 · cited 3× · PMID 36979870 · DOI 10.3390/biomedicines11030891