NCT04468698

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

12 months

First QC Date

July 9, 2020

Last Update Submit

July 14, 2020

Conditions

SurgeryPneumoperitoneumIntra Abdominal Pressure

Outcome Measures

Primary Outcomes (1)

  • Intraabdominal volume

    During pneumoperitoneum insufflation before surgery

Secondary Outcomes (2)

  • Driving pressure

    During pneumoperitoneum insufflation before surgery

  • Plateau pressure

    During pneumoperitoneum insufflation before surgery

Study Arms (1)

Global cohort

A global cohort is built merging data from three studies

Other: Peritoneum insufflation

Interventions

Peritoneum insufflationOTHER

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.

Global cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing pneumoperitoenum insufflation during general anesthesia and mechanical venitlation.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital la Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 13, 2020

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

July 1, 2020

Last Updated

July 16, 2020

Record last verified: 2020-07

Locations

ES(1)