Measuring breathing activity during loading and support.

Validity and reliability of advanced monitoring for identifying changes in respiratory muscles in healthy volunteers: the DRIVE study’ - The DRIVE study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON58116

Enrollment

Registered

2025-07-08

Start date

2025-11-17

Completion date

Unknown

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory failure, acute respiratory failure, respiratory insufficiency breathing problems, trouble with breathing

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Adults >18 yearsBody mass index (BMI) =18 and =30 kg/m2Able to comprehend and sign the Information letter and Informed Consent (IC) prior to enrolment in the study.

Exclusion criteria

Exclusion criteria: Contra-indication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode placement)Contra-indications for oesophageal balloon catheter placement (e.g. history of gastric bypass surgery, gastro-oesophageal junction surgery, oesophageal stricture, recent upper gastrointestinal hemorrhage or known/suspected varices).Previous history of cancer requiring radiotherapy or surgery to the lungs Suspected of not being able to comply with the trial protocol Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and/or take part in the studyNot have fasted for at least 2 hoursKnown respiratory pathology (i.e. COPD, asthma, fibrosis) 

Design outcomes

Primary

Measure	Time frame
In this explorative study, we will determine the validity of multiple techniques to detect changes in respiratory muscle effort. The primary outcome will be the strength of association between ?Pes (gold standard to measure respiratory muscle effort) and the variables derived from respiratory muscle US, EIT and parasternal EMG. We will compute the Pearson correlation coefficient, or if data violate normality assumptions Spearman’s rank correlation coefficient will be used as a non-parametric alternative.	—

Measure

Time frame

In this explorative study, we will determine the validity of multiple techniques to detect changes in respiratory muscle effort. The primary outcome will be the strength of association between ?Pes (gold standard to measure respiratory muscle effort) and the variables derived from respiratory muscle US, EIT and parasternal EMG. We will compute the Pearson correlation coefficient, or if data violate normality assumptions Spearman’s rank correlation coefficient will be used as a non-parametric alternative.

—

Secondary

Measure	Time frame
To assess the sensitivity of each measurement technique to detect physiological change between conditions, we will calculate the Standardized Response Mean (SRM) for both ?Pes and the variables derived from respiratory muscle US, EIT and parasternal EMG. The SRM is defined as the mean of the individual change scores (post–pre) divided by the standard deviation of those change scores.	—

Countries

Netherlands

Contacts

Public ContactB Fazzini

Radboud Universitair Medisch Centrum

jonne.doorduin@radboudumc.nl0031243611111

Outcome results