Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04789603 |
| Other study ID # |
CBAS-2020-03 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 10, 2021 |
| Est. completion date |
June 1, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
Universitat Internacional de Catalunya |
| Contact |
Jacobo Rodríguez-Sanz, PhD |
| Phone |
+34636136789 |
| Email |
jrodriguezs[@]uic.es |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Since the beginning of the pandemic caused by SARC-CoV 2, more than 81 million cases have
been diagnosed and caused around 1,7 million deaths. Currently, a drug is being sought for
the treatment of coronavirus. The worldwide effort to create an effective and safe COVID-19
vaccine is beginning to yield results. Several vaccines now have been authorized around the
globe; many more remain in development. Nonetheless, in the absence of effective
pharmacological treatment and given the virus's transmission capacity, different alternatives
have been proposed to stop the transmission of the virus. Therefore, these preventive
measures against transmission are expected to remain in force for some time.
The transmission of the virus occurs from person-to-person; different studies conclude that
transmission occurs by aerosols from respiratory droplets. The optimal distance between
people to stop person-to-person transmission is uncertain. For this reason and given that
there is no effective drug, transmission prevention is of great importance especially for
pandemic mitigation in community settings.
The World Health Organization (WHO) established simple precautions to prevent the spread of
the virus such as physical distancing, wearing a mask, keeping rooms well ventilated,
avoiding crowds, cleaning your hands, and coughing into a bent elbow or tissue. For this
reason, the use of the mask has been proposed in several countries, being mandatory in many
of them, for use in the health environment and daily use.
The WHO recommends different types of masks depending on the person, where it will be used,
or the population incidence in the area. Wearing a medical /surgical mask is recommended for
people over 60, those who have underlying medical conditions, feel unwell, and/or look after
an ill family member. For health workers, respirator masks (such as FFP2, FFP3, N95, N99)
should be used in settings where procedures are generating aerosols.
The use of a mask could imply an inspiratory and expiratory restraint and generate a feeling
of discomfort in many people. It is responsible for an increase in the inspiratory and
expiratory pressures generated. This feeling of discomfort and the increment of pressures
causes shallow and forced breathing and increases the respiratory accessory musculature
activation.
Person et al. observed that the subjects who used a mask felt dyspnea clinically and
significantly higher than those who did not use it. However, to our knowledge, no study has
analyzed the parameters of physical effort, respiratory parameters, self-perceived dyspnea,
and muscle activation using different types of masks in healthy subjects. For this reason,
the present study hypothesis is that there are no changes between wearing and not-wearing a
mask (surgical or N-95) in the effort and ventilatory parameters, even though there may be an
increase in the tone of the cervical muscles or the perception of dyspnea using a face mask.
This study aims to observe the effect that the surgical mask and the N-95 mask have in the
distance walked, in the oxygenometry, in the heart rate, in the sensation of dyspnea, and the
tone of the inspiratory accessory muscles during the 6 minutes walking test.
Procedure After verifying that the subjects meet the inclusion criteria and sign the consent,
they will be given a registration number. An investigator will observe the number in a random
list and included the participant in one of the three groups (without a mask, with a surgical
mask, and with N95 mask). This researcher will make an initial registration of demographic
data (gender, age, weight, height, cardiorespiratory pathology, smoker, number of cigarettes
per day, a sport performed, hours of daily sport, and days of sport per week). Before the
test, all the subjects will have to remain for 30 minutes without a mask, breathing normally.
This phase will be called the resting phase. Subsequently, the subjects will go to the area
where the 6MWT will be carried out. Each one of them will be performed the test according to
the group to which they will be assigned. An investigator, blinded to the subsequent
assessment, will encourage the participants to take the 6MWT according to the recommendations
mentioned above. After performing the 6MWT, all subjects will go to the assessment area. All
the subjects will wear a surgical mask so that the researcher can not know to which group
they have been assigned. Besides, this researcher will not have access to the registration
number or the 6-minute walking test area.
At the end of each resting phase, SpO2 and baseline HR will be recorded. After every 6MWT,
the HR, SpO2, and self-perceived dyspnea will be recorded. The muscle tone will also be
assessed with the MyotonPRO in middle scalene and SCM.
Subjects will have the option of retaking the test, going through all the phases mentioned
above.
Description:
Since the beginning of the pandemic caused by SARC-CoV 2, more than 81 million cases have
been diagnosed and caused around 1,7 million deaths. Currently, a drug is being sought for
the treatment of coronavirus. The worldwide effort to create an effective and safe COVID-19
vaccine is beginning to yield results. Several vaccines now have been authorized around the
globe; many more remain in development. Nonetheless, in the absence of effective
pharmacological treatment and given the virus's transmission capacity, different alternatives
have been proposed to stop the transmission of the virus. Therefore, these preventive
measures against transmission are expected to remain in force for some time.
The transmission of the virus occurs from person-to-person; different studies conclude that
transmission occurs by aerosols from respiratory droplets. The optimal distance between
people to stop person-to-person transmission is uncertain. For this reason and given that
there is no effective drug, transmission prevention is of great importance especially for
pandemic mitigation in community settings.
The World Health Organization (WHO) established simple precautions to prevent the spread of
the virus such as physical distancing, wearing a mask, keeping rooms well ventilated,
avoiding crowds, cleaning your hands, and coughing into a bent elbow or tissue. For this
reason, the use of the mask has been proposed in several countries, being mandatory in many
of them, for use in the health environment and daily use.
The WHO recommends different types of masks depending on the person, where it will be used,
or the population incidence in the area. Wearing a medical /surgical mask is recommended for
people over 60, those who have underlying medical conditions, feel unwell, and/or look after
an ill family member. For health workers, respirator masks (such as FFP2, FFP3, N95, N99)
should be used in settings where procedures are generating aerosols.
The use of a mask could imply an inspiratory and expiratory restraint and generate a feeling
of discomfort in many people. It is responsible for an increase in the inspiratory and
expiratory pressures generated. This feeling of discomfort and the increment of pressures
causes shallow and forced breathing and increases the respiratory accessory musculature
activation.
Person et al. observed that the subjects who used a mask felt dyspnea clinically and
significantly higher than those who did not use it. However, to our knowledge, no study has
analyzed the parameters of physical effort, respiratory parameters, self-perceived dyspnea,
and muscle activation using different types of masks in healthy subjects. For this reason,
the present study hypothesis is that there are no changes between wearing and not-wearing a
mask (surgical or N-95) in the effort and ventilatory parameters, even though there may be an
increase in the tone of the cervical muscles or the perception of dyspnea using a face mask.
This study aims to observe the effect that the surgical mask and the N-95 mask have in the
distance walked, in the oxygenometry, in the heart rate, in the sensation of dyspnea, and the
tone of the inspiratory accessory muscles during the 6 minutes walking test.
Procedure After verifying that the subjects meet the inclusion criteria and sign the consent,
they will be given a registration number. An investigator will observe the number in a random
list and included the participant in one of the three groups (without a mask, with a surgical
mask, and with N95 mask). This researcher will make an initial registration of demographic
data (gender, age, weight, height, cardiorespiratory pathology, smoker, number of cigarettes
per day, a sport performed, hours of daily sport, and days of sport per week). Before the
test, all the subjects will have to remain for 30 minutes without a mask, breathing normally.
This phase will be called the resting phase. Subsequently, the subjects will go to the area
where the 6MWT will be carried out. Each one of them will be performed the test according to
the group to which they will be assigned. An investigator, blinded to the subsequent
assessment, will encourage the participants to take the 6MWT according to the recommendations
mentioned above. After performing the 6MWT, all subjects will go to the assessment area. All
the subjects will wear a surgical mask so that the researcher can not know to which group
they have been assigned. Besides, this researcher will not have access to the registration
number or the 6-minute walking test area.
At the end of each resting phase, SpO2 and baseline HR will be recorded. After every 6MWT,
the HR, SpO2, and self-perceived dyspnea will be recorded. The muscle tone will also be
assessed with the MyotonPRO in middle scalene and SCM.
Subjects will have the option of retaking the test, going through all the phases mentioned
above.
