NCT03501446

Brief Summary

The capnodynamic method non-invasively calculates effective lung volume (ELV) continuously during surgery. In this study ELV is compared to functionalresidual capacity (FRC) measured with Nitrogen Multiple Breath Wash out (NMBW) at 0 and 5 cm H2O Positive End Expiratory Pressure (PEEP) in patients scheduled for neck surgery at the Karolinska University Hospital, Solna, Sweden.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2015

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

11 months

First QC Date

April 10, 2018

Last Update Submit

April 10, 2018

Conditions

Ventilator LungGas ExchangePulmonary Function

Keywords

PEEP optimizationLung volumes

Outcome Measures

Primary Outcomes (1)

  • Effective lung volume

    Lung volume measurements during mechanical ventilation based on CO2 dynamics and a differentiated Fick's principle.

    Continous measurements during general anaesthesia and mechanical ventialtion, 45 minutes-2 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals scheduled for neck surgery at Karolinska university hospital

You may qualify if:

  • Individuals without current heart or lung disease

You may not qualify if:

  • Obesitas
  • Heart disease
  • Lung disease
  • Current smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Perioperative Medicine and Intensive Care, Karolinska University Hospital

Solna, Stockholm County, SE-171 76, Sweden

Location

Study Officials

  • Håkan Björne, PhD

    Karolinska Institutet

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in anaesthesia and intensive care

Study Record Dates

First Submitted

April 10, 2018

First Posted

April 18, 2018

Study Start

December 1, 2014

Primary Completion

October 21, 2015

Study Completion

October 21, 2015

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations

SE(1)