Transpulmonary Driving Pressure & Intra-abdominal Pressure Relationship

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03435913
Study type	Interventional
Source	Hospital Universitario La Fe
Contact
Status	Completed
Phase	N/A
Start date	April 19, 2018
Completion date	November 21, 2018

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT04515485` - A Volumetric Nomogram for Height, Weight, and Intra Abdominal Volume
Completed	`NCT01725477` - Laparoscopic Tubal Patency Assessment	N/A
Recruiting	`NCT01093430` - Is the Anterior Superior Iliac Spine a Useful Landmark at Laparoscopy?	N/A
Recruiting	`NCT01093079` - Laparoscopic Versus Open Partial Nephrectomy - Surgical and Oncological Outcomes	N/A
Completed	`NCT00535990` - Minimally Invasive Surgery (MIS) Database for the Purpose of Research
Completed	`NCT01092013` - Comparative Evaluation of Simulator Based and Traditional In-surgery Laparoscopic Camera Training's Efficiency in Novices	N/A
Recruiting	`NCT06044909` - Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance
Completed	`NCT06255080` - Comparing Skills Acquisition on Different Laparoscopy Software	N/A
Not yet recruiting	`NCT05389241` - Laparoscopic Augmented Reality for Identification of Liver Lesions - a Pre-clinical Randomized Cross-over Trial	N/A
Enrolling by invitation	`NCT03234543` - Remote Ischemic Conditioning in Abdominal Surgery	N/A
Recruiting	`NCT02827292` - Effect of Music on Inflammatory Response During Laparoscopic Surgery	N/A
Not yet recruiting	`NCT06092684` - The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery	Phase 3
Terminated	`NCT01008709` - Comparison Study of Two Different Surgical Clips During Laparoscopic Urologic Surgery	N/A
Active, not recruiting	`NCT05363813` - Post-market Clinical Follow-up Study of Reusable Clip Applier Cartridge Devices for LAParoscopic Surgery	N/A
Completed	`NCT03330236` - EEG - Guided Anesthetic Care and Postoperative Delirium	N/A
Recruiting	`NCT05031182` - Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.	N/A
Active, not recruiting	`NCT05302622` - Detecting the Most Efficient Residency Time for Laparoscopic Simulators	N/A
Recruiting	`NCT03684291` - Hemodynamic Effects of Ventilation Modes
Recruiting	`NCT06117748` - Volume-Controlled Ventilation and Pressure-Controlled Ventilation Volume Guaranteed in Obese Patients in Laparoscopic-Assisted Surgery	N/A
Recruiting	`NCT03739944` - Different Surgical Approaches in Patients of Early-stage Cervical Cancer	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms