CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13 enrolled
Drug / intervention
Pressure measurement during exhalation through a device consisted of a drinking straw of an inner diameter of 5mm, a disposable mouthpiece and a manometer +1 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04447586
NCT04447586N/ACompleted

Soft Drink Straw as an Alternative Device of Creating Positive Expiratory Pressure (PEP) in Thoracic Surgery Patients

University of Thessaly·interventional·Posted Jun 25, 2020·Updated Jul 16, 2020

In Brief

A clinical study evaluating Pressure measurement during exhalation through a device consisted of a drinking straw of an inner diameter of 5mm, a disposable mouthpiece and a manometer and Pressure measurement during exhalation through an alternative PEP device/soft drink straw. for Thoracic Surgery. Completed, enrolled 13 participants across 1 site.

Detailed Summary

Is there any possibility that patients who undergone thoracic surgery could use a simple soft drink straw as an alternative PEP device? The present study was performed to test the suitability and effect of a soft drink straw as an alternative Positive Expiratory Pressure device in patients undergone thoracic surgery and includes two sub-exploratory areas. Before and after the measurements, the volunteers' saturation, heart rate, respiratory rate, systolic and diastolic blood pressure, dyspnea, thoracotomy pain and Cough Peak Expiratory Flow was measured. The first part of the research, that refers to the most appropriate command for exhalation from a straw of a certain inner diameter (5mm), was carried out by using a device consisted of drinking straw, disposable mouthpiece and manometer, which valued the developed pressures during the exhalation attempts. Patients did not have visual contact with the manometer. The effectiveness of two commands (Command A: "blow continuously so that you feel little resistance during exhalation" and Command B: "blow continuously so that you feel moderate resistance during exhalation") was estimated by comparing the average of the developing pressures for every command, that occur during exhalation, with the therapeutic range of pressure. This part of the study was a cross-sectional transition and every volunteer performed 3 attempts, for each command. The second part of the research was conducted for the evaluation of the benefits of the use of a drinking straw as an alternative device. A number of n = 8 volunteers (intervention group), who were selected from the overall sample using the closed envelope method. Taking into account the results of the first part of the research, the respondents were asked to exhale as indicated by the command that was selected before, performing 3 sets of 10 repetitions, that included short breaks between sets. The remaining volunteers (n = 5) consisted the control group. Finally, all patients were re-examined in order to measure the Cough Peak Expiratory Flow , dyspnea, pain, saturation, heart and respiratory rate, and systolic and diastolic blood pressure, after the intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGreece
CollaboratorsAttikon Hospital

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 25, 2020
Enrollment StartFeb 12, 2020
Primary CompletionMar 8, 2020
TodayJul 2, 2026
Enrollment to primary: 26 daysPosted 6.0 years ago

Interventions

Pressure measurement during exhalation through a device consisted of a drinking straw of an inner diameter of 5mm, a disposable mouthpiece and a manometerother

Participants performed exhalation attempts through a device consisted of a drinking straw of an inner diameter of 5mm, a disposable mouthpiece and a manometer, following the instructions of Command A and B (A:"please blow continuously so that you feel low resistance during exhalation" and B:"please blow continuously so that you feel moderate resistance during exhalation") in a specific order for each group. Every volunteer performed 3 attempts for each command.The outputs of the 3rd attempt were used to the study.

Pressure measurement during exhalation through an alternative PEP device/soft drink straw.other

Participants were requested to exhale as indicated by the "right" command (Command A or B), for 3 sets of 10 repetitions. This procedure included short breaks between sets.