Pneumoperitoneum Increases Mean Expiratory Flow Rate: an Observational Study in Healthy-lung Patients

January 8, 2024 updated by: Balázs Sütő
Upon introducing pneumoperitoneum our research team noticed a reduction in expiration time displayed on the screen of the anesthesia machine. Since most respirators do not directly indicate the length of expiratory time and the average expiratory flow rate, we decided to investigate whether pneumoperitoneum really accelerates expiratory flow rate and thus shortens expiratory time.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Detailed Description

Furthermore we also intended to investigate which ventilation parameters these changes can be correlated with, elucidating the factors contributing to the acceleration of expiration..

This study aims to uncover the physiological mechanisms behind alterations in respiratory dynamics during and after pneumoperitoneum, offering valuable insights that may aid in refining ventilation strategies in the context of laparoscopic procedures.

Study Type

Observational

Enrollment (Estimated)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Baranya
      • Pécs, Baranya, Hungary, 7623
        • Department of Anaesthesia and Intensive Care, Medical School, University of Pécs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Helthy lung patients, over age 18 years, males and femailes together.

Description

Inclusion Criteria:

  • elective laparoscopic abdominal surgery, healthy lung patients, age over 18 years. Obrained, written informed consent to partake in the research.

Exclusion Criteria:

chronic obstructive pulmonary disease, bronchial asthma, silicosis, and those with a history of previous lung surgery, patients under 18 years of age, those who had not provided consent, and pregnant individuals were excluded from the study.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pneumoperitoneum increases mean expiratory flow rate
Time Frame: during surgery
Elevated intraabdominal pressure leads to a decrease in respiratory compliance and an increase in peak inspiratory pressure., therefore (consequently), expiration commences with a higher pressure difference.
during surgery
Expiration time would be shortened, resulting in a potentially higher flow rate
Time Frame: during surgery
We assumed (hypothesized) that the expiration time would be shortened, resulting in a potentially higher flow rate compared to pre-pneumoperitoneum conditions. Additionally, we also conducted calculations to establish correlations between respiratory parameters and the mean increment in expiratory flow rate relative to the baseline.
during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

January 31, 2024

Study Completion (Estimated)

January 31, 2024

Study Registration Dates

First Submitted

January 8, 2024

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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