Ignite Creation Date:
2024-05-06 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03435913
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2018-01-30
Brief Title:
Transpulmonary Driving Pressure and Intra-abdominal Pressure Relationship During Laparoscopic Surgery
Sponsor:
Hospital Universitario La Fe
Organization:
Hospital Universitario La Fe
Study Overview
Official Title:
Assessment of Transpulmonary Driving Pressure and Intra-abdominal Pressure Relationship at Different Levels of Positive End-expiratory Pressure PEEP During Laparoscopic Surgery
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None