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

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.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Ventilation; Atelectasis; Distribution of Ventilation
• Intervention / Treatment: Device: Ventilation 20-40-60; Device: Ventilation 60-40-20; Device: Ventilation 40-60-20

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erik Wikström, MD; Phone Number: +46196025907; Email: erik.wikstrom@regionorebrolan.se
• Study Contact Backup: Name: Pether Jildenstål, PhD; Email: pether.jildenstal@regionorebrolan.se

Study Locations

• Sweden
  • Örebro, Sweden, 70185
    • Recruiting
    • Region Örebro Län
    • Contact: Erik Wikström, MD; Phone Number: +46196025907; Email: erik.wikstrom@regionorebrolan.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 20-40-60	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.
Experimental: 60-40-20	Device: Ventilation 60-40-20; The respiratory rate during mechanical ventilation will be altered from 60 to 40 and finally to 20 breaths per minute.
Experimental: 40-60-20	Device: Ventilation 40-60-20; The respiratory rate during mechanical ventilation will be altered from 40 to 60 and finally to 20 breaths per minute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of ventilation	Gas distribution of ventilation between different regions of interest monitored with electrical impedance tomography.	During the prostatectomy procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of ventilation	Gas distribution of ventilation measured as center of ventilation monitored with electrical impedance tomography.	During the prostatectomy procedure

Collaborators and Investigators

• Sponsor: Region Örebro County
• Investigators: Study Director: Pether Jildenstål, PhD, Örebro University, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: 281122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No