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

• Sponsor: Hospital Universitario La Fe (Other)
• Overall Status: Completed
• CT.gov ID: NCT04468698
• Collaborator: (none)
• Enrollment: 204
• Location: 1
• Actual Duration (Months): 18
• Patients Per Site Per Month: 11.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Surgery; Pneumoperitoneum; Intra Abdominal Pressure	Other: Peritoneum insufflation

Study Design

• Study Type: Observational
• Actual Enrollment: 204 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official 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
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Jul 1, 2020

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Intraabdominal volume [During pneumoperitoneum insufflation before surgery]

Secondary Outcome Measures

1. 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

2. Plateau pressure [During pneumoperitoneum insufflation before surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital la Fe	Valencia		Spain	46026

Sponsors and Collaborators

• Hospital Universitario La Fe

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oscar Diaz-Cambronero, Principal Investigator, Hospital Universitario La Fe
• ClinicalTrials.gov Identifier: NCT04468698
• Other Study ID Numbers: VoIPP
• First Posted: Jul 13, 2020
• Last Update Posted: Jul 16, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pneumoperitoneum

Study Results

No Results Posted as of Jul 16, 2020