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

Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04468698
• Other study ID #: VoIPP
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: Hospital Universitario La Fe
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: July 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Intra Abdominal Pressure
• Pneumoperitoneum
• Surgery

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital la Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraabdominal volume		During pneumoperitoneum insufflation before surgery
Secondary	Driving pressure	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	During pneumoperitoneum insufflation before surgery
Secondary	Plateau pressure	This is the pressure in the airway during the mechanical venitilation inspiratory pause time	During pneumoperitoneum insufflation before surgery