Clinical trial NCT05393115: Respiratory Muscle Fatigue at Different Breathing Modes
Official title: Does Inspiratory Pressure Wave Form Influence Respiratory Muscle Fatigue and Metabolism During Resistive Breathing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims at investigating if time to respiratory muscle fatigue and metabolism are influenced by the pressure wave form mode applied during resistive breathing.

Detailed description: In healthy subjects fitted with a nasogastric double balloon catheter and breathing at a resistance, the investigators will measure time to failure, Borg ratings, VO2, VCO2, flow, esophageal-, gastric- and airway-pressure. This will be done during breathing at either a square wave or triangle wave pressure waveform, in random order and trials separated by \>two days. Further respiratory muscle fatigue will be investigated pre and post intervention by maximal esophageal pressure generation (voluntary and with cervical magnetic stimulation).

Eligibility criteria: Inclusion Criteria:

* Healthy men or women
* Age ≥18 and ≤60 years
* BMI ≥ 20 and ≤30

Exclusion Criteria:

* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous and present neurologic (e.g. ataxia), musculoskeletal (e.g. muscular dystrophy) or mental illnesses (e.g. schizophrenia)
* History of mechanical ventilation, COVID-19 with respiratory complications, lung cancer
* Part of lung resected
* Presence of dyspepsia/heart-burn/abdominal pain
* Presence of esophageal varices
* Presence of liver disease
* Presence of esophageal hernia
* Pregnancy
* Failure to comply with transcranial magnetic stimulation adult safety screen
* History of epilepsy, metal implants in head or jaw
* Acute or chronic lung diseases, e.g. asthma, COPD, bronchitis etc.
* Lack of ability to cooperate

Primary outcomes:
measure: Time to task failure (Tlim)
timeFrame: Up to two months between the two different breathing trials (randomized order)
Secondary outcomes:
measure: Respiratory muscle pressures
timeFrame: Up to two months between the two different breathing trials (randomized order)
measure: Tidal volume
timeFrame: Up to two months between the two different breathing trials (randomized order)
measure: Respiratory work
timeFrame: Up to two months between the two different breathing trials (randomized order)
measure: Ratings of perceived exertion
timeFrame: Up to two months between the two different breathing trials (randomized order)
measure: Metabolism
timeFrame: Up to two months between the two different breathing trials (randomized order)
measure: Respiratory rate
timeFrame: Up to two months between the two different breathing trials (randomized order)
measure: Minute ventilation
timeFrame: Up to two months between the two different breathing trials (randomized order)
measure: Insp. and expiratory time
timeFrame: Up to two months between the two different breathing trials (randomized order)
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Mathias Krogh Poulsen
state: Danmark
Study officials:
References: