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Regional Distribution of Ventilation at Different Respiratory Rates

Regional Distribution of Ventilation in Different Respiratory Rates: A Study of Mechanically Ventilated Patients Undergoing Robot-assisted Laparoscopic Prostatectomy

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06171477
Enrollment
15
Registered
2023-12-14
Start date
2024-05-02
Completion date
2024-12-31
Last updated
2024-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atelectasis, Distribution of Ventilation, Mechanical Ventilation

Brief 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.

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.

Interventions

DEVICEVentilation 20-40-60

The respiratory rate during mechanical ventilation will be altered from 20 to 40 and finally to 60 breaths per minute.

DEVICEVentilation 60-40-20

The respiratory rate during mechanical ventilation will be altered from 60 to 40 and finally to 20 breaths per minute.

DEVICEVentilation 40-60-20

The respiratory rate during mechanical ventilation will be altered from 40 to 60 and finally to 20 breaths per minute.

Sponsors

Region Örebro County
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients planned for robot-assisted laparoscopic prostatectomy * \> 18 years * Consent to take part in the study

Exclusion criteria

* Impaired cognitive function * Previously known lung disease * Insufficient skills in Swedish language to understand information about the study

Design outcomes

Primary

MeasureTime frameDescription
Distribution of ventilationDuring the prostatectomy procedureGas distribution of ventilation between different regions of interest monitored with electrical impedance tomography.

Secondary

MeasureTime frameDescription
Distribution of ventilationDuring the prostatectomy procedureGas distribution of ventilation measured as center of ventilation monitored with electrical impedance tomography.

Countries

Sweden

Contacts

Primary ContactErik Wikström, MD
erik.wikstrom@regionorebrolan.se+46196025907
Backup ContactPether Jildenstål, PhD
pether.jildenstal@regionorebrolan.se

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026