Intra-Abdominal Pressure Effect on Intra-Abdominal Volume and Airway Pressures During Laparoscopy

Intra-Abdominal Pressure Effect on Intra-Abdominal Volume and Airway Pressures During Pneumoperitoneum Insufflation - a Patient-Level Meta-Analysis of Three Randomized Clinical Trials

During pneumoperitoneum insufflation the insufflated gas increase intra-abdominal pressure. The generated pressure can lead to a different increase in volume depending on the abdominal cavity and patients' characteristics.

The primary objective is to determine the relationship between intraabdominal pressure (IAP) and intraabdominal volume (IAV) during pneumoperitoneum insufflation. The secondary objective is to determine the rate of abdominal-thoracic transmission (ATT) assessing the correlation between IAP and respiratory driving pressure (ΔPRS).

Study Overview

• Status: Completed
• Conditions: Pneumoperitoneum; Surgery; Intra Abdominal Pressure
• Intervention / Treatment: Other: Peritoneum insufflation

• Study Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46026
    • Hospital la Fé

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing pneumoperitoenum insufflation during general anesthesia and mechanical venitlation.

Description

Inclusion Criteria:

• Enrolled one of the three studies (IPPCollapse I, II or III).
• underwent an initial insufflation procedure with a stepwise change in intraabdominal pressure to record Intraabdominal volume
• data from insufflation at 5 cmH2O of PEEP

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Global cohort; A global cohort is built merging data from three studies	Other: Peritoneum insufflation; Before surgery pneumoperitoneum is established by insufflating gas into the abdomen. Intraabdominal pressure (IAP) is set to 15 mmHg for initial abdominal stretching and then decreased in a stepwise manner down until 8 mmHg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraabdominal volume	During pneumoperitoneum insufflation before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Driving pressure	This is the pressure that exert a stress on the respiratory system during mechanical ventilation. It is calculated by subtracting the positive endexpiratory pressure from plateau pressure	During pneumoperitoneum insufflation before surgery
Plateau pressure	This is the pressure in the airway during the mechanical venitilation inspiratory pause time	During pneumoperitoneum insufflation before surgery

Collaborators and Investigators

• Sponsor: Hospital Universitario La Fe

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): July 1, 2020

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (ACTUAL): July 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: VoIPP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No