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

NCT05532748 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-09-08

No results posted yet for this study

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

Interventions

DEVICE

Respiratory exercise protocol with the modified Pachon's incentive

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.

DEVICE

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

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.

Sponsors & Collaborators

  • Universidad del Valle, Colombia

    lead OTHER

Principal Investigators

  • Noraelena Mera Quintero, Pt, MsC(c) · universidad del Valle

  • Esther C Wilches Luna, Pt, PhD · Universidad del Valle

  • Vicente A Benavides Cordoba, Pt, PhD · Universidad del Valle

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05532748 on ClinicalTrials.gov