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

Completed

• Conditions: Pneumoperitoneum; Intra Abdominal Pressure; Surgery
• Interventions: Other: Peritoneum insufflation

• Registration Number: NCT04468698
• Lead Sponsor: Hospital Universitario La Fe

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-12-31
• Status Verified: 2020-07
• Study Completion: 2020-07-01
• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-13
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Global cohort	Peritoneum insufflation	A global cohort is built merging data from three studies

Primary Outcome Measures

Name	Time	Method
Intraabdominal volume	During pneumoperitoneum insufflation before surgery

Secondary Outcome Measures

Name	Time	Method
Plateau pressure	During pneumoperitoneum insufflation before surgery	This is the pressure in the airway during the mechanical venitilation inspiratory pause time
Driving pressure	During pneumoperitoneum insufflation before surgery	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

Trial Locations

Locations (1)

Hospital la Fe; 🇪🇸 Valencia, Spain