NCT05702554

Brief Summary

The present investigation is focused to assess the effects of positive end-expiratory pressure (PEEP) on respiratory system compliance in obese patients invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

January 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

August 5, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

January 19, 2023

Last Update Submit

August 5, 2023

Conditions

Respiratory System MechanicsPneumoperitoneum

Outcome Measures

Primary Outcomes (1)

  • Intraoperative respiratory system mechanics

    respiratory system compliance defined as volume variation to pressure variation ratio

    1 hour following PEEP application

Secondary Outcomes (1)

  • respiratory pulmonary complications incidence

    up to 7 days after surgery

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult obese (body mass index ≥ 30 kg/m2) patients undergoing invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum

You may qualify if:

  • Adult obese (body mass index ≥ 30 kg/m2) patients undergoing invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum will be enrolled, upon the acquisition of informed consent.

You may not qualify if:

  • Will be excluded all the patients with the following conditions: american society of anesthesiologists (ASA) score ≥ 4; severe cardiopathy, intracranial hypertension, tracheosthomy, previous cardio-thoracic surgery, pulmonary hypertrension, broncho-pleural fistula, pulmonary emphysema, pnumothorax, chronic respiratory failure, chronic obstructive pulmonary disease, pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Università degli Studi di Perugia

Perugia, Umbria, Italy, 06156, Italy

RECRUITING

Università degli Studi di Perugia

Perugia, 06123, Italy

RECRUITING

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Gianmaria Cammarota

Study Record Dates

First Submitted

January 19, 2023

First Posted

January 27, 2023

Study Start

August 5, 2023

Primary Completion

September 30, 2023

Study Completion

December 31, 2023

Last Updated

August 9, 2023

Record last verified: 2023-08

Locations

IT(2)