Regional Distribution of Ventilation at Different Respiratory Rates

Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06171477
• Other study ID #: 281122
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Region Örebro County
• Contact: Erik Wikström, MD
• Phone: +46196025907
• Email: erik.wikstrom[@]regionorebrolan.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atelectasis
• Mechanical Ventilation
• Pulmonary Atelectasis

Intervention

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

Locations

Country	Name	City	State
Sweden	Region Örebro län	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of ventilation	Gas distribution of ventilation between different regions of interest monitored with electrical impedance tomography.	During the prostatectomy procedure
Secondary	Distribution of ventilation	Gas distribution of ventilation measured as center of ventilation monitored with electrical impedance tomography.	During the prostatectomy procedure