Respiratory Muscle Fatigue at Different Breathing Modes

May 24, 2022 updated by: Mathias Krogh Poulsen, Aalborg University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Danmark
      • Aalborg, Danmark, Denmark, 9220
        • Recruiting
        • Mathias Krogh Poulsen
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to task failure (Tlim)
Time Frame: 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.
Up to two months between the two different breathing trials (randomized order)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Respiratory muscle pressures
Time Frame: Up 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).
Up to two months between the two different breathing trials (randomized order)
Tidal volume
Time Frame: Up 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)
Up to two months between the two different breathing trials (randomized order)
Respiratory work
Time Frame: Up 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)
Up to two months between the two different breathing trials (randomized order)
Ratings of perceived exertion
Time Frame: Up 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.
Up to two months between the two different breathing trials (randomized order)
Metabolism
Time Frame: Up 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).
Up to two months between the two different breathing trials (randomized order)
Respiratory rate
Time Frame: Up 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)
Up to two months between the two different breathing trials (randomized order)
Minute ventilation
Time Frame: Up 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)
Up to two months between the two different breathing trials (randomized order)
Insp. and expiratory time
Time Frame: Up 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)
Up to two months between the two different breathing trials (randomized order)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aalborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Eso_pres_fatigue

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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