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

NCT ID: NCT04468698

Last Updated: 2020-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-07-01

Brief Summary

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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

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Conditions

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Surgery Pneumoperitoneum Intra Abdominal Pressure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Global cohort

A global cohort is built merging data from three studies

Peritoneum insufflation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario La Fe

OTHER

Sponsor Role lead

Responsible Party

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Oscar Diaz-Cambronero

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital la Fe

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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VoIPP

Identifier Type: -

Identifier Source: org_study_id

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