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Completed

NCT Number: NCT04468698

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

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).

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Key information

Conditions

Surgery Digestive System Diseases Intra Abdominal Pressure Peritoneal Diseases Pneumoperitoneum

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital la Fe

Valencia, 46026, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peritoneum insufflation

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.

Primary outcomes

  1. Intraabdominal volume

    Time frame: During pneumoperitoneum insufflation before surgery

Secondary outcomes

  1. Driving pressure

    Time frame: 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

  2. Plateau pressure

    Time frame: During pneumoperitoneum insufflation before surgery

    This is the pressure in the airway during the mechanical venitilation inspiratory pause time

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Fe

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 13, 2020
Registry last updated
Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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