Skip to content

Respiratory Muscle Fatigue at Different Breathing Modes

Does Inspiratory Pressure Wave Form Influence Respiratory Muscle Fatigue and Metabolism During Resistive Breathing

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05393115
Enrollment
12
Registered
2022-05-26
Start date
2021-10-01
Completion date
2022-12-01
Last updated
2022-05-26

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

Conditions

Healthy

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).

Interventions

OTHERSquare wave breathing

difference in time to failure from the two breathing modes

Sponsors

Aalborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Time to task failure (Tlim)Up to two months between the two different breathing trials (randomized order)The time (s) from the subject starts to breathe under the experimental condition, and until task failure will be measured. Task failure is defied by either subject intolerance to continue or by lacking ability of the subject to maintain the target pressure and/or timing. From a previous publication (Bellemare and Grassino, JAP, 1982), it is estimated that subjects will reach Tlim between 30min to 1 hour. If breathing is continued after 1 hour, task failure will not happen as breathing can be continued indefinitely.

Secondary

MeasureTime frameDescription
Tidal volumeUp to two months between the two different breathing trials (randomized order)Tidal Volume (ml) will be measured with a flowsensor (Hans Rudolph) through a pressure box (ICU lab, KleisTek)
Respiratory workUp to two months between the two different breathing trials (randomized order)Work of breathing (j), will be calculated from outcome measure 2 and 9 (pressure (cmH2O) and insp. and expiratory time (s)). Measured with pressure box (ICU lab, KleisTek)
Ratings of perceived exertionUp to two months between the two different breathing trials (randomized order)Borg Dyspnea Scale, from 0-10 where 0 is no effort at all and 10 is maximal breathing effort.
Respiratory muscle pressuresUp to two months between the two different breathing trials (randomized order)Respiratory muscle pressure will be measured by esophageal and gastric pressure (in cmH2O) using a naso gastric catheter fitted with double balloons (Nutrivent) connected to a pressure sensor (ICU lab, KleisTek).
Respiratory rateUp to two months between the two different breathing trials (randomized order)Respiratory rate (breaths/min) will be measured with a flowsensor (Hans Rudolph) through a pressure box (ICU lab, KleisTek)
Minute ventilationUp to two months between the two different breathing trials (randomized order)Minyte ventilation (l/min) will be measured with a flowsensor (Hans Rudolph) through a pressure box (ICU lab, KleisTek)
Insp. and expiratory timeUp to two months between the two different breathing trials (randomized order)Insp. and expiratory time (s) will be measured with a flowsensor (Hans Rudolph) through a pressure box (ICU lab, KleisTek)
MetabolismUp to two months between the two different breathing trials (randomized order)Energy expenditure calculated from VO2 (ml/min) nad VCO2 (ml/min) with e.g Weir equation. VO2 and VCO2 are measured with Beacon (Mermaid care).

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026