Pneumoperitoneum Increases Mean Expiratory Flow RateNCT06212258
Pneumoperitoneum Increases Mean Expiratory Flow Rate: an Observational Study in Healthy-lung Patients
An observational study of Pneumoperitoneum Increases Mean Expiratory Flow Rate, run by Balázs Sütő at 1 site in Hungary.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumoperitoneum Increases Mean Expiratory Flow Rate
- What is being tested?
- Abdominal Laparascopy
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 1 siteHungary
- Study dates
- 1 Oct 2023to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Helthy lung patients, over age 18 years, males and femailes together.
Who may be able to join
- elective laparoscopic abdominal surgery, healthy lung patients, age over 18 years. Obrained, written informed consent to partake in the research.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Department of Anaesthesia and Intensive Care, Medical School, University of Pécs
Pécs, Baranya, 7623
About this study
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.
Read the 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.
- Being tested
- Abdominal Laparascopy
- Keywords
- mechanical ventilation; body mass index; chest compliance; pneumoperitoneum; expiratory flow rate, intraabdominal pressure, laparoscopic surgery
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal LaparascopyProcedure or surgery
pneumoperitoneum
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumoperitoneum increases mean expiratory flow rate
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.
Measured: during surgery
Expiration time would be shortened, resulting in a potentially higher flow rate
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.
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Oct 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumoperitoneum Increases Mean Expiratory Flow RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balázs Sütő
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Balázs Sütő, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212258
- Sponsor's protocol ID
- 9746 - PTE - 2023
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumoperitoneum Increases Mean Expiratory Flow Rate: an Observational Study in Healthy-lung Patients
- ClinicalTrials.gov ID
- NCT06212258
- Acronym / sponsor ID
- 9746 - PTE - 2023
- Keywords
- mechanical ventilation; body mass index; chest compliance; pneumoperitoneum; expiratory flow rate, intraabdominal pressure, laparoscopic surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Balázs SütőUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Helthy lung patients, over age 18 years, males and femailes together.
Key inclusion criteria (1 listed)
- elective laparoscopic abdominal surgery, healthy lung patients, age over 18 years. Obrained, written informed consent to partake in the research.
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal Laparascopypneumoperitoneum | Procedure or surgery | – |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumoperitoneum Increases Mean Expiratory Flow Rate, run by Balázs Sütő at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumoperitoneum increases mean expiratory flow rate (time frame: during surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024; AzTrials last refreshed its copy on 31 Oct 2026.