Distribution of Pulmonary Ventilation With the Modified Pachon Incentive vs. Branded Respiratory Incentive

NCT05532748 | Unknown

• 1 other identifier: 031-022
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Ventilation

Keywords

Tomography; Electric Impedance; Spirometry; Respiratory Therapy; Equipment and Supplies

Outcome Measures

Primary Outcomes (2)

• EELI Delta (ΔEELI)

  Measures the change in the average end-expiratory pulmonary impedance between before and after an intervention. Measurement Unit: Arbitrary Impedance Units (A.U)

  Event 1 "pre": after the first 2 minutes of calm breathing. Event 2 "intra": In the last repetition of the third series of the use of the device. Event 3 "post": 2 minutes after finishing the three series of 10 repetitions

• MTV ROI

  Minute regional tidal variation. Measurement Unit: Arbitrary Impedance Units (A.U)

  Event 1 "pre": after the first 2 minutes of calm breathing. Event 2 "intra": In the last repetition of the third series of the use of the device. Event 3 "post": 2 minutes after finishing the three series of 10 repetitions

Secondary Outcomes (2)

• Heart rate

  after two minutes of calm breathing, after two minutes of the use of each respiratory incentive

• Oxygen saturation

  after two minutes of calm breathing, after two minutes of the use of each respiratory incentive

Study Arms (2)

Modified Pachon's incentive, then Branded incentive "Triflo II®"

EXPERIMENTAL

The first measurement with the tomograph will be made using the modified Pachon's incentive, and a week later the measurement will be made using the branded incentive

Device: Respiratory exercise protocol with the modified Pachon's incentive; Device: Respiratory exercise protocol with Branded respiratory incentive, "Triflo II®"

Branded incentive "Triflo II®", then modified Pachon's incentive

ACTIVE COMPARATOR

The first measurement with the tomograph will be made using the branded incentive, and a week later the measurement will be made using the modified Pachon's incentive.

Device: Respiratory exercise protocol with the modified Pachon's incentive; Device: Respiratory exercise protocol with Branded respiratory incentive, "Triflo II®"

Interventions

Respiratory exercise protocol with the modified Pachon's incentive DEVICE

With the participant sitting on a chair, with their back against the backrest, they will hold the device with the hand that is most comfortable for them and place the mouthpiece in their mouth, ensuring a correct seal with their lips. You will be asked to take a slow, deep breath, fully stretching the condom, and hold your breath for at least 5 seconds. Expiration will be performed passively through the device without removing it from the mouth and without performing any forced maneuver. There will be 3 series of 10 breaths with a 1-minute rest between series. The total number of breaths for the entire session will be 30; the maneuver will end once the series and repetitions are finished. You will be asked to remove the mouthpiece from your mouth and breathe for 3 minutes at a gentle intensity through your nose without extra effort. All these instructions will be explained through a video.

Also known as: IMP

Branded incentive "Triflo II®", then modified Pachon's incentive; Modified Pachon's incentive, then Branded incentive "Triflo II®"

Respiratory exercise protocol with Branded respiratory incentive, "Triflo II®" DEVICE

With the participant sitting on a chair, with their back against the backrest, they will hold the device with the hand that is most comfortable for them and place the mouthpiece in their mouth, ensuring a correct seal with their lips. You will be asked to take a smooth deep breath lifting as many spheres as you can and hold your breath for at least 5 seconds. Expiration will be performed passively through the device without removing it from the mouth and without performing any forced maneuver. There will be 3 series of 10 breaths with a 1-minute rest between series. The total number of breaths for the entire session will be 30; the maneuver will end once the series and repetitions are finished. You will be asked to remove the mouthpiece from your mouth and breathe gently through your nose for 3 minutes without extra effort. All these instructions will be explained through a video.

Also known as: Triflo II®

Branded incentive "Triflo II®", then modified Pachon's incentive; Modified Pachon's incentive, then Branded incentive "Triflo II®"

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People aged between 18-65 years
• People with clinical stability, defined as the absence of any acute illness during the previous 6 weeks and a Charlson index score of 0-1 (12% mortality/year- no comorbidity)
• People with body mass index (BMI) 18.5 - 35 Kg/m2
• People without mental or cognitive alterations
• People who accept informed consent

You may not qualify if:

• People with pacemakers, cardioverters or cardio defibrillators.
• People with metal implants
• People with any condition in which the registration in the CT scanner signal is low.
• Women in pregnancy
• Participants with injuries, skin changes or presence of devices that prevent the placement of the electrode belt around the chest.
• People with a high level of physical activity according to the IPAQ questionnaire short version
• People whose spirometry registers obstruction or restriction
• People who do not understand the verbal command of the incentive technique

Sponsors & Collaborators

• Universidad del Valle, Colombia: lead

Study Sites (1)

Universidad del Valle

Cali, Valle del Cauca Department, 760043, Colombia

Location

Study Officials

• Noraelena Mera Quintero, Pt, MsC(c)

  universidad del Valle

  PRINCIPAL INVESTIGATOR

• Esther C Wilches Luna, Pt, PhD

  Universidad del Valle

  STUDY DIRECTOR

• Vicente A Benavides Cordoba, Pt, PhD

  Universidad del Valle

  STUDY DIRECTOR

Central Study Contacts

Noraelena Mera Quintero

CONTACT

+573187983544; nora.elena.mera@correounivalle.edu.co

Esther C Wilches Luna

CONTACT

esther.wilches@correounivalle.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor of results will be masked, the data will be delivered encrypted with a code for the analysis of the measurement of each of the respiratory incentives.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Model Details: The objective of this research is to compare the distribution of pulmonary ventilation using Electrical Impedance Tomography during the use of the Incentivo Modificado de Pachón and a commercial respiratory incentive, in healthy adults from the City of Cali (Colombia), for which A sample of 20 healthy subjects (10 men and 10 women) between 18 and 65 years of age will be used, who, after meeting the selection criteria, will undergo the first ventilation measurement using EIT with the incentive that has been randomly assigned to the participant, The second measurement will be carried out one week after the first measurement with the other incentive has been carried out, to complete the washout period, both measurements will be carried out by the principal investigator.

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 8, 2022
• Study Start: September 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: from January 2023 to January 2033
• Access Criteria: for future publications or for the development of subsequent projects

Locations

CO (1)