Mechanical VentilationNCT06171477
Regional Distribution of Ventilation at Different Respiratory Rates
A study testing Ventilation 20-40-60, Ventilation 60-40-20 and Ventilation 40-60-20 in people with Mechanical Ventilation and Atelectasis, run by Region Örebro County at 1 site in Sweden.
Trial summary
This study will investigate the distribution of gas during mechanical ventilation in patients undergoing robot assisted laparoscopic prostatectomy. The gas distribution of ventilation are monitored and data extracted using electric impedance tomography in different respiratory rates. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Mechanical Ventilation, Atelectasis, Distribution of Ventilation
- What is being tested?
- Ventilation 20-40-60, Ventilation 60-40-20 and Ventilation 40-60-20
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 2 May 2024to 31 Dec 2024
- Phase
- Interventional
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients planned for robot-assisted laparoscopic prostatectomy
- > 18 years
- Consent to take part in the study
Who cannot join
- Impaired cognitive function
- Previously known lung disease
- Insufficient skills in Swedish language to understand information about the study
Trial locations and contacts
1 site in 1 country.
Pether Jildenstål, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Region Örebro län
Örebro, 70185
Erik Wikström, MD, +46196025907, erik.wikstrom@regionorebrolan.se
About this study
Official title: Regional Distribution of Ventilation in Different Respiratory Rates: A Study of Mechanically Ventilated Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
This study will investigate the distribution of gas during mechanical ventilation in patients undergoing robot assisted laparoscopic prostatectomy. The gas distribution of ventilation are monitored and data extracted using electric impedance tomography in different respiratory rates.
Read the detailed description
Mechanical ventilation during anaesthesia and intensive care often results in an uneven gas distribution of ventilation. Patients anaesthetized for laparoscopic surgery and patients positioned i a Trendelenburg position is particularly at risk.
A less harmful mode of ventilation could possible lead to a more optimal ventilation with avoidance of ventilator induced lung injuries. The project will investigate if volume controlled ventilation with a higher respiratory frequency can be used in this purpose.
The researchers intend to investigate patients, without previously known lung disease, undergoing robot-assisted laparoscopic prostatectomy. After the patients have given informed consent, they will be included in the project. The distribution of ventilation will be monitored with electric impedance tomography (EIT). Once the patients have been anaesthetized, positioned with the head down and the surgical procedure have been started with insufflation of carbon dioxide we will start our test.
The investigators will perform three episodes of standardized ventilation with the respiratory rate (RR) of 20, 40 and 60. With a higher RR the tidal volume will be reduced tom maintain a constant inhaled minute volume. Data will be collected from the EIT-equipment, the anaesthesia machine and the monitoring system.
- Being tested
- Ventilation 20-40-60, Ventilation 60-40-20, Ventilation 40-60-20
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation 20-40-60Device
The respiratory rate during mechanical ventilation will be altered from 20 to 40 and finally to 60 breaths per minute.
Ventilation 60-40-20Device
The respiratory rate during mechanical ventilation will be altered from 60 to 40 and finally to 20 breaths per minute.
Ventilation 40-60-20Device
The respiratory rate during mechanical ventilation will be altered from 40 to 60 and finally to 20 breaths per minute.
| Study group | Role | What they receive |
|---|---|---|
| 20-40-60 | Experimental | Not described Receives: Device: Ventilation 20-40-60 |
| 60-40-20 | Experimental | Not described Receives: Device: Ventilation 60-40-20 |
| 40-60-20 | Experimental | Not described Receives: Device: Ventilation 40-60-20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of ventilation
Gas distribution of ventilation between different regions of interest monitored with electrical impedance tomography.
Measured: During the prostatectomy procedure
Secondary outcomes (1)
Distribution of ventilation
Gas distribution of ventilation measured as center of ventilation monitored with electrical impedance tomography.
Measured: During the prostatectomy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start2 May 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pether Jildenstål, PhD, Study director, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171477
- Sponsor's protocol ID
- 281122
- Status last verified
- May 2024
- First submitted
- 6 Dec 2023
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Distribution of Ventilation in Different Respiratory Rates: A Study of Mechanically Ventilated Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
- ClinicalTrials.gov ID
- NCT06171477
- Acronym / sponsor ID
- 281122
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Dec 2023 (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.
This study will investigate the distribution of gas during mechanical ventilation in patients undergoing robot assisted laparoscopic prostatectomy. The gas distribution of ventilation are monitored and data extracted using electric impedance tomography in different respiratory rates.
Detailed description
Mechanical ventilation during anaesthesia and intensive care often results in an uneven gas distribution of ventilation. Patients anaesthetized for laparoscopic surgery and patients positioned i a Trendelenburg position is particularly at risk.
A less harmful mode of ventilation could possible lead to a more optimal ventilation with avoidance of ventilator induced lung injuries. The project will investigate if volume controlled ventilation with a higher respiratory frequency can be used in this purpose.
The researchers intend to investigate patients, without previously known lung disease, undergoing robot-assisted laparoscopic prostatectomy. After the patients have given informed consent, they will be included in the project. The distribution of ventilation will be monitored with electric impedance tomography (EIT). Once the patients have been anaesthetized, positioned with the head down and the surgical procedure have been started with insufflation of carbon dioxide we will start our test.
The investigators will perform three episodes of standardized ventilation with the respiratory rate (RR) of 20, 40 and 60. With a higher RR the tidal volume will be reduced tom maintain a constant inhaled minute volume. Data will be collected from the EIT-equipment, the anaesthesia machine and the monitoring system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20-40-60 | Experimental | Device: Ventilation 20-40-60 |
| 60-40-20 | Experimental | Device: Ventilation 60-40-20 |
| 40-60-20 | Experimental | Device: Ventilation 40-60-20 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients planned for robot-assisted laparoscopic prostatectomy
- > 18 years
- Consent to take part in the study
Key exclusion criteria (3 listed)
- Impaired cognitive function
- Previously known lung disease
- Insufficient skills in Swedish language to understand information about 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 |
|---|---|---|
| Ventilation 20-40-60The respiratory rate during mechanical ventilation will be altered from 20 to 40 and finally to 60 breaths per minute. | Device | 20-40-60 |
| Ventilation 60-40-20The respiratory rate during mechanical ventilation will be altered from 60 to 40 and finally to 20 breaths per minute. | Device | 60-40-20 |
| Ventilation 40-60-20The respiratory rate during mechanical ventilation will be altered from 40 to 60 and finally to 20 breaths per minute. | Device | 40-60-20 |
Primary outcome
Distribution of ventilation
Time frame: During the prostatectomy procedure
Gas distribution of ventilation between different regions of interest monitored with electrical impedance tomography.
1 secondary outcome
Distribution of ventilation
Time frame: During the prostatectomy procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
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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.
Pether Jildenstål, PhD contact
Pether Jildenstål, PhD study director
Örebro University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilation 20-40-60, Ventilation 60-40-20 and Ventilation 40-60-20 in people with Mechanical Ventilation and Atelectasis, run by Region Örebro County at 1 site in Sweden.
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 3 inclusion and 3 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 3 May 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 Sweden. 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?
Contact Erik Wikström, MD (+46196025907, erik.wikstrom@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of ventilation (time frame: During the prostatectomy procedure). 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 3 May 2024.