Respiratory Muscle Fatigue at Different Breathing Modes

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05393115
• Other study ID #: Eso_pres_fatigue
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: May 2022
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Healthy

Intervention

Other:
• Square wave breathing
difference in time to failure from the two breathing modes

Locations

Country	Name	City	State
Denmark	Mathias Krogh Poulsen	Aalborg	Danmark

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to task failure (Tlim)	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.	Up to two months between the two different breathing trials (randomized order)
Secondary	Respiratory muscle pressures	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).	Up to two months between the two different breathing trials (randomized order)
Secondary	Tidal volume	Tidal Volume (ml) will be measured with a flowsensor (Hans Rudolph) through a pressure box (ICU lab, KleisTek)	Up to two months between the two different breathing trials (randomized order)
Secondary	Respiratory work	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)	Up to two months between the two different breathing trials (randomized order)
Secondary	Ratings of perceived exertion	Borg Dyspnea Scale, from 0-10 where 0 is no effort at all and 10 is maximal breathing effort.	Up to two months between the two different breathing trials (randomized order)
Secondary	Metabolism	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).	Up to two months between the two different breathing trials (randomized order)
Secondary	Respiratory rate	Respiratory rate (breaths/min) will be measured with a flowsensor (Hans Rudolph) through a pressure box (ICU lab, KleisTek)	Up to two months between the two different breathing trials (randomized order)
Secondary	Minute ventilation	Minyte ventilation (l/min) will be measured with a flowsensor (Hans Rudolph) through a pressure box (ICU lab, KleisTek)	Up to two months between the two different breathing trials (randomized order)
Secondary	Insp. and expiratory time	Insp. and expiratory time (s) will be measured with a flowsensor (Hans Rudolph) through a pressure box (ICU lab, KleisTek)	Up to two months between the two different breathing trials (randomized order)