NCT06171477

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

May 2, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

December 6, 2023

Last Update Submit

May 2, 2024

Conditions

Mechanical VentilationAtelectasisDistribution of Ventilation

Outcome Measures

Primary Outcomes (1)

  • Distribution of ventilation

    Gas distribution of ventilation between different regions of interest monitored with electrical impedance tomography.

    During the prostatectomy procedure

Secondary Outcomes (1)

  • Distribution of ventilation

    During the prostatectomy procedure

Study Arms (3)

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

Interventions

Ventilation 20-40-60DEVICE

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

20-40-60
Ventilation 60-40-20DEVICE

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

60-40-20
Ventilation 40-60-20DEVICE

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

40-60-20

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Örebro län

Örebro, 70185, Sweden

RECRUITING

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Pether Jildenstål, PhD

    Örebro University, Sweden

    STUDY DIRECTOR

Central Study Contacts

Erik Wikström, MD

CONTACT

+46196025907erik.wikstrom@regionorebrolan.se

Pether Jildenstål, PhD

CONTACT

pether.jildenstal@regionorebrolan.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 14, 2023

Study Start

May 2, 2024

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

May 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)