Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05532748 |
| Other study ID # |
031-022 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2022 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
September 2022 |
| Source |
Universidad del Valle, Colombia |
| Contact |
Noraelena Mera Quintero |
| Phone |
+573187983544 |
| Email |
nora.elena.mera[@]correounivalle.edu.co |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Incentive spirometry is a method to stimulate deep breathing and maximum sustained
inflations, which provides participants with visual feedback on the inspiratory volume
achieved, favoring lung inflation. Its multiple benefits and ease of use favor adherence,
making it a common device used in the clinical environment.
This device is used in pathologies or procedures that can cause decreased function and
respiratory mechanics, such as thoracoabdominal surgeries, and is indicated to reduce the
incidence of postoperative pulmonary complications. It is also indicated in the presence of
pulmonary atelectasis or conditions that predispose to the development of pulmonary
atelectasis, in patients with prolonged bed rest, patients with neuromuscular disease,
patients with spinal cord injury, and patients undergoing coronary bypass, among others.
In 2004, students from the Universidad del Valle carried out an investigation whose result
was the creation of the Incentivo Modificado de Pachon, a handcrafted design device that
allows mobilizing flows ranging from 600 CC/sec to more than 1400 CC/sec, which characterizes
it as a flow respiratory incentive.
In 2020, the device obtained the endorsement of the Superintendence of Industry and Commerce,
however, to date no studies have been carried out that objectively verify the effect that the
modified Pachon's incentive (Incentivo Modificado de Pachon by the name in Spanish) has on
the distribution of ventilation in comparison with another Branded respiratory incentive.
Electrical Impedance Tomography is a diagnostic tool that, employing a belt of electrodes
connected around the user's chest, uses the electrical characteristics of the tissue, to
provide information in a non-invasive, continuous way, on foot. bedside and radiation-free on
pulmonary ventilation and perfusion, as it allows repeated imaging of tidal volume
distribution, as well as distinguishing the characteristic regional filling and emptying of
each lung, all in real-time and safely.
In this study, the distribution of pulmonary ventilation between the modified Pachon's
incentive vs. another Branded respiratory incentive will be compared, through electrical
impedance tomography, in a healthy population of the city of Cali.
The hypothesis to be tested is that the distribution of Pulmonary ventilation measured by
Electrical Impedance Tomography is similar between the modified Pachon's incentive and
another Branded flow respiratory incentive.
Description:
The variables to be measured are:
Main variables:
- EELI Delta (ΔEELI): Measures the change in the average end-expiratory pulmonary
impedance before and after an intervention
- MTV ROI: Minute regional tidal variation
Secondary variables:
- IPAQ: Instrument that provides information on estimated energy expenditure in 24 hours
in the different areas of daily life
- Charlson index: Relates long-term mortality with the participant's comorbidity
- %FEV1 pred: Percentage of the predicted forced expired volume in the first second
- %FVC pred: Percentage of predicted forced vital capacity
- %FVC/FEV1: Percentage of predicted of relationship between forced vital capacity and
FEV1
- Labor Occupation: Includes the labor function of the worker
- Level of schooling: the highest level of studies completed or in progress
- Marital status: situation determined by your family relationships, from marriage or
kinship
- Socioeconomic Stratum: Classification in strata of residential properties
- Personal history: Compilation of information on the health of the person and pathologies
that he/she suffers from
- Height: Measurement of the height of the human body from the feet to the roof of the
cranial vault
- Weight: Force with which bodies are attracted towards the center of the earth by the
action of gravity
- BMI: Relationship between weight and height
- Heart rate: Number of times the heart contracts in one minute
- Respiratory rate: Number of breaths in one minute
- Oxygen Saturation: Measurement of the amount of oxygen available in the blood
- Dyspnea: Difficulty breathing
Materials and Instruments:
The instruments that will be used in the study will be: Height rod, scale, Spirometer,
Incentivo Modificado de Pachon, Hudson Flow Respiratory Incentive, equipment to measure
impedance (Pulmovista), and data collection format. These are described below:
- Modified Pachon's incentive (Incentivo Modificado de Pachon by the name in Spanish):
handmade device that imitates conventional respiratory incentives, but is made with
recyclable, low-cost materials and is also easy to manufacture. Modified in 2004 in a
research project by students from the Universidad del Valle, they defined that the
Modified Pachon's incentive allows for the mobilization of flows that oscillate between
600 cc/sec up to more than 1400 cc/sec which characterizes it as a flow incentive. The
materials used for its construction are a non-lubricated buretrol and a Today brand
condom
- Triflo® II Respiratory Incentive: A method of encouraging deep voluntary breathing,
which provides participants with visual feedback on inspiratory volume, employing 3
color-coded balls in three chambers, with a mouthpiece and tube. The minimum flow is
marked on each chamber: 600, 900, and 1200 ml/Seg.. It is manufactured by HUDSON RCI
- PulmoVista 500®: it is an electrical impedance tomograph, from Dräger. The data is
continuously represented in the form of images, curves, and parameters to observe
ventilation continuously and directly in various lung regions, as well as the changes
that occur in lung volumes at the end of expiration, non-invasively, in time. real and
directly next to the bed
- Spirometer: This is a device that is commonly used to assess how well the lungs are
working by measuring how much air you breathe in, how much you breathe out, and how
quickly you breathe out. Spirometry is used to diagnose asthma, chronic obstructive
pulmonary disease, and other diseases that affect breathing. For this study, a
medgraphics cardiorespiratory diagnostics® brand spirometer will be used, which works
with the breeze suite 6.4.1.44 SP4 system
- Stadiometer: it is a height meter that is fixed to the wall or support and is used to
accurately measure people, so that when it is placed under it, the stadiometer will rest
on their head, indicating the height on the dial. exactly who is using it. For this
study, a SECA model 213® stadiometer will be used
- Scale: Device used to measure weights. For this study, a SECA® brand scale will be used
For this research, a data collection format was designed:
• Format created by the researcher consisting of a section on sociodemographic information,
personal and family history, anthropometric data, level of physical activity, lung function
data and results on ventilation and global and regional lung impedance for each individual
To measure clinical stability and the level of physical activity, the following instruments
will be used:
- Charlson index: it is a life expectancy evaluation system, depending on the age at which
it is evaluated, and the subject's comorbidities. In addition to age, it consists of 19
pathology items with their respective rating, which, if present, have been found to have
a specific influence on the subject's life expectancy
- International Physical Activity Questionnaire (IPAQ) short version: IPAQ researchers
developed several versions of the instrument according to the number of questions (short
or long). The short version consists of 7 items and provides information about the time
the person spends performing moderate and vigorous intensity activities, walking and
sitting The research will be carried out in four stages: Preparation for the study,
design, and adjustment of instruments, data collection, and data analysis. Ordered
according to the logical steps to follow within the development of obtaining the
required data
Phase 1: Preparation for the study At this stage, the search for initial information will be
carried out, for this a bibliographic review will be carried out for the present study that
includes research published in different databases, related to the validation and comparison
of medical devices, the use of electrical impedance tomography and studies related to the use
of respiratory incentive in the clinical setting and their levels of evidence. Once this is
done, the research approach, the study design, the form of selection and sample size, and the
writing of the document will be carried out For the development of this study, the main
researcher will carry out 24-hour training in the handling of the equipment with expert
personnel in its handling The informed consent will be designed and the written research work
will be sent to the ethics committee to receive the endorsement
Phase 2: Design and adjustment of instruments The data collection instrument will be designed
For the standardization of anthropometric measurements (weight and height), Standardized
Operating Procedures 1 and 2 will be used For the measurement of electrical impedance
tomography, Standard Operating Procedures 3, designed for projects previously carried out by
the GIESC research group, will be used. "Effect of two lung reexpansion techniques on the
ventilation of participants undergoing cardiovascular surgery. Controlled clinical trial
phase II b" The pilot test will be carried out with 5 healthy subjects who will not be part
of the sample, they will be informed about the research, they will be asked to sign the
informed consent and the measurements and data collection will be carried out with the
designed data collection format. by the researcher
Phase 3: Data Collection:
- Call for participants For the recruitment of healthy volunteers between 18-65 years of
age in the community of Santiago de Cali, direct contact will be made with people from
the administrative areas of the Universidad del Valle, from the research groups of the
Universidad del Valle, family and friends who will initially be provided with
information about the objectives of the research and will be invited to participate The
electrical impedance tomography will be performed in the movement laboratory located in
the health faculty of the Universidad del Valle and the spirometries will be performed
at the Hospital Universitario del Valle
- Data collection protocol:
- Performance of spirometry This measurement will be carried out at the Hospital
Universitario del Valle, it will be carried out by the researcher, who is a
physiotherapist specializing in cardiopulmonary physiotherapy. The day of the test
will begin with the completion of the informed consent, this will be read and
explained to the participant and will continue to the signature. On this day, the
researcher will fill out the sociodemographic data of the participant, weight and
height measurement, Charlson index, and IPAQ abbreviated questionnaire, according
to the instructions defined in the Standard Operating Procedures designed for each
one, in the data collection format Spirometry will be performed according to the
institutional protocol of the Hospital Universitario del Valle. The duration of
this procedure will take approximately 1 hour
- Randomization The randomization to choose which will be the first device that each
participant will use and to which the first ventilation measurement will be carried
out using electrical impedance tomography will be carried out by simple
randomization The first measurement will be carried out with the incentive that has
been randomly assigned to the participant, the second measurement will be carried
out one week after the first measurement has been carried out with the other
incentive, with the objective that the washing period is fulfilled, both
measurements will be carried out by the principal investigator For the measurement
of the Electrical Impedance Tomography, a standardized operating procedure will be
carried out, and for the application of the protocol for the use of respiratory
incentives, the instructions defined in the standardized operating procedures
carried out for their use will be followed. The duration of this procedure will be
approximately 30 minutes for each measurement
- Moments of electrical impedance tomography measurement
Once the patient is connected to the tomograph, once it is verified that it is being measured
properly, that the patient is well positioned and that the signal is of high quality, the
recording will begin. tomograph record; After the first two minutes of calm breathing have
elapsed, the first event will be marked, which will be recorded as "pre", and the use of the
corresponding respiratory incentive will begin. The proper use of the device will be
previously explained to you through a video that will illustrate the correct way to use it.
The participant will receive visual feedback from the device when the condom is raised within
the buretrol in the case of the Modified Pachon's incentive or when the spheres are raised in
the branded incentive Three series of ten breaths will be performed, with a 1-minute rest
between series. In the last repetition of the third series, the second event will be marked,
which will be recorded as "intra" The maneuver will be finished once the series and
repetitions are finished, removing the mouthpiece from the participant's mouth and they will
be asked to continue breathing calmly for 2 minutes, after which the third event will be
marked, which will be recorded as "post". And the recording of the record will be terminated
At the beginning and the end of the intervention, clinical data will be taken (heart rate and
oxygen saturation) and 2 minutes after finishing the test The session may be interrupted if
the participant does not wish to continue with the intervention, if the participant shows
intolerance to the maneuver After each measurement is finished with each participant, the
equipment will be disinfected
o Quality Control
1. To guarantee the quality of the registered information, the main investigator will carry
out random reviews in which he will corroborate the coherence between the original
information of the tomographer, that of the registration in the formats and that of the
database. The detected errors will be corrected
2. An external person to the study, who will not participate in the measurements, will
randomly review the formats once every 15 days to verify the information before entering
it into the database. Additionally, once a month a meeting will be held with the
research group to socialize project progress
