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

NCT04447586 | Completed

• 2 other identifiers: 101ΣΕ2/16-01-2020725/25/11/2019
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thoracic Surgery

Keywords

Soft drink straw; Alternative PEP device; Patients undergone thoracic surgery; Cough

Outcome Measures

Primary Outcomes (1)

• Comparison by Commands A and B

  Comparison of the outcoming pressures by Commands A and B

  15 minutes

Study Arms (4)

Patients following Command A and B

ACTIVE COMPARATOR

This group of patients followed the Commands A and B with this specific order, and performed 3 exhalation attempts for each command.

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

Patients following Command B and A

ACTIVE COMPARATOR

This group of patients followed the Commands B and A with this specific order, and performed 3 exhalation attempts for each command.

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

intervention group

ACTIVE COMPARATOR

Intervention group was requested to exhale as indicated by the "right" command, performing 3 sets of 10 repetitions.

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

control group

NO INTERVENTION

Did not perform exhalation attempts by the "right" command.

Interventions

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

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.

Patients following Command A and B; Patients following Command B and A

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.

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients undergone thoracic surgery
• no limit of age
• mesosternal or lateral incision
• hemodynamically stable
• supplied with an O2 mixture of below 50%
• full-conscious
• systolic pressure below 150 cmH20
• nd and 3rd postoperative day.

You may not qualify if:

• history of chronic respiratory disease with severe symptoms
• tendency to vomit
• cardiac arrhythmia due to atrial fibrillation postoperatively
• angina
• decrease in saturation ≤90
• dizziness
• fainting
• palpitations

Sponsors & Collaborators

• University of Thessaly: lead
• Attikon Hospital: collaborator

Study Sites (1)

Attikon Hospital

Athens, Greece

Location

Related Publications (15)

• Zhang XY, Wang Q, Zhang S, Tan W, Wang Z, Li J. The use of a modified, oscillating positive expiratory pressure device reduced fever and length of hospital stay in patients after thoracic and upper abdominal surgery: a randomised trial. J Physiother. 2015 Jan;61(1):16-20. doi: 10.1016/j.jphys.2014.11.013. Epub 2014 Dec 19.

  PMID: 25534580 BACKGROUND

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  PMID: 21146420 BACKGROUND

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  PMID: 19878100 BACKGROUND

• Sehlin M, Ohberg F, Johansson G, Winso O. Physiological responses to positive expiratory pressure breathing: a comparison of the PEP bottle and the PEP mask. Respir Care. 2007 Aug;52(8):1000-5.

  PMID: 17650355 BACKGROUND

• Dagan Y, Wiser I, Weissman O, Farber N, Hundeshagen G, Winkler E, Kazula-Halabi T, Haik J. An Improvised "Blow Glove" Device Produces Similar PEP Values to a Commercial PEP Device: An Experimental Study. Physiother Can. 2014 Summer;66(3):308-12. doi: 10.3138/ptc.2013-31.

  PMID: 25125786 BACKGROUND

• Banner AS. Cough: physiology, evaluation, and treatment. Lung. 1986;164(2):79-92. doi: 10.1007/BF02713631. No abstract available.

  PMID: 3084882 BACKGROUND

• Johnson D, Hurst T, Thomson D, Mycyk T, Burbridge B, To T, Mayers I. Respiratory function after cardiac surgery. J Cardiothorac Vasc Anesth. 1996 Aug;10(5):571-7. doi: 10.1016/s1053-0770(96)80130-3.

  PMID: 8841860 BACKGROUND

• Kulnik ST, MacBean V, Birring SS, Moxham J, Rafferty GF, Kalra L. Accuracy of portable devices in measuring peak cough flow. Physiol Meas. 2015 Feb;36(2):243-57. doi: 10.1088/0967-3334/36/2/243. Epub 2015 Jan 13.

  PMID: 25582526 BACKGROUND

• Rose L, McKim D, Leasa D, Nonoyama M, Tandon A, Kaminska M, O'Connell C, Loewen A, Connolly B, Murphy P, Hart N, Road J. Monitoring Cough Effectiveness and Use of Airway Clearance Strategies: A Canadian and UK Survey. Respir Care. 2018 Dec;63(12):1506-1513. doi: 10.4187/respcare.06321. Epub 2018 Sep 11.

  PMID: 30206128 BACKGROUND

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  PMID: 25926373 BACKGROUND

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  PMID: 30402388 BACKGROUND

• Holdgate A, Asha S, Craig J, Thompson J. Comparison of a verbal numeric rating scale with the visual analogue scale for the measurement of acute pain. Emerg Med (Fremantle). 2003 Oct-Dec;15(5-6):441-6. doi: 10.1046/j.1442-2026.2003.00499.x.

  PMID: 14992058 BACKGROUND

• Fiore JF Jr, Chiavegato LD, Denehy L, Paisani DM, Faresin SM. Do directed cough maneuvers improve cough effectiveness in the early period after open heart surgery? Effect of thoracic support and maximal inspiration on cough peak expiratory flow, cough expiratory volume, and thoracic pain. Respir Care. 2008 Aug;53(8):1027-34.

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• Liverani B, Nava S, Polastri M. An integrative review on the positive expiratory pressure (PEP)-bottle therapy for patients with pulmonary diseases. Physiother Res Int. 2020 Jan;25(1):e1823. doi: 10.1002/pri.1823. Epub 2019 Nov 25.

  PMID: 31762162 BACKGROUND

Related Links

• Breathing exercises with positive expiratory pressure after abdominal surgery - The current physical therapy practice in Sweden
• Is retained mucus a risk factor for the development of postoperative atelectasis and pneumonia? -- Implications for the physiotherapist

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kostantinos Grigoriadis, Dr

  Attikon Hospital

  STUDY DIRECTOR

• Garyfallia Pepera, Dr

  University of Thessaly

  STUDY CHAIR

• Dimitrios Dougenis, Prof

  National and Kapodistrian University of Athens

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: The first part of the study was carried out by using a device consisted of a drinking straw of an inner diameter of 5mm, a disposable mouthpiece and a manometer.The sample of this part included all the volunteers.The effectiveness of each command (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") was estimated by comparing the average of the developing pressures during exhalation attempts arose by the corresponding command with the therapeutic range of pressure.Every volunteer performed 3 attempts for each command.The outputs of the 3rd attempt were used to the study.For the second part of the study, a number of n=8 volunteers (intervention group) was selected from the total sample and was requested to exhale as indicated by the "right" command, for 3 sets of 10 repetitions, included short breaks between sets.The remaining volunteers (n=5) consisted the control group.

Study Record Dates

• First Submitted: June 14, 2020
• First Posted: June 25, 2020
• Study Start: February 12, 2020
• Primary Completion: March 8, 2020
• Study Completion: March 8, 2020
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)