Regional Distribution of Ventilation at Different Respiratory Rates

NCT ID: NCT06171477

Last Updated: 2024-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-02

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Mechanical Ventilation Atelectasis Distribution of Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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20-40-60

Group Type EXPERIMENTAL

Ventilation 20-40-60

Intervention Type DEVICE

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

60-40-20

Group Type EXPERIMENTAL

Ventilation 60-40-20

Intervention Type DEVICE

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

40-60-20

Group Type EXPERIMENTAL

Ventilation 40-60-20

Intervention Type DEVICE

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

Interventions

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Ventilation 20-40-60

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Region Örebro County

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pether Jildenstål, PhD

Role: STUDY_DIRECTOR

Örebro University, Sweden

Locations

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Region Örebro län

Örebro, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Erik Wikström, MD

Role: CONTACT

+46196025907

Pether Jildenstål, PhD

Role: CONTACT

Facility Contacts

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Erik Wikström, MD

Role: primary

+46196025907

Other Identifiers

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281122

Identifier Type: -

Identifier Source: org_study_id

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