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Effect of Assisted Autogenic Drainage In Children Suffering From Pneumonia

Primary Purpose

Pneumonia Childhood

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Assistive autogenic Drainage
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia Childhood focused on measuring Pneumonia, Drainage, Autogenic Drainage

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • class III & IV on pneumonia severity index.
  • Both genders are included under study.
  • Patients on 2nd & 3rd generation anti-biotic therapy for pneumonia are included.

Exclusion Criteria:

  • Children with Musculoskeletal, Neuromuscular and Cardiovascular co-morbidities.
  • Children with diagnosed lobular pneumonia are also excluded.

Sites / Locations

  • Fauji Foundation Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Assistive Autogenic Drainage

Arm Description

Autogenic drainage (AD) is a breathing technique that uses controlled breathing and least amount of coughing to clear secretions from your chest. It involves you hearing and feeling your secretions as you breathe out and controlling the urge to cough until secretions are high up and easily cleared with little effort.

Outcomes

Primary Outcome Measures

Atrial Blood Gases
change from baseline Atrial Blood Gases (PH, carbon dioxide partial pressure (PCO2), partial pressure of Oxygen PO2, saturation SPO2)

Secondary Outcome Measures

Pulse rate
change from baseline pulse rate
Pulse rate
change from day 1 pulse rate
Pulse rate
change from day 3 pulse rate
Respiratory
change from baseline Respiratory rate
Respiratory
change from day 1 Respiratory rate
Respiratory
change from day 3 Respiratory rate
Chest Xray
change of chest Xrays From baseline
Pediatric Early Warning System (PEWS)
change of PEWs from baseline
Pediatric Early Warning System (PEWS)
change of PEWs from day 1
Pediatric Early Warning System (PEWS)
change of PEWs from day 3

Full Information

First Posted
October 13, 2018
Last Updated
September 16, 2020
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT03710759
Brief Title
Effect of Assisted Autogenic Drainage In Children Suffering From Pneumonia
Official Title
Effect of Assisted Autogenic Drainage In Children Suffering From Pneumonia - a Quasi Experimental Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
June 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Quasi experimental study with duration will be of 6 month, data will be collected from Fauji Foundation Hospital, Rawalpindi. Sample size was calculated from open epi tool (2017) was n=60. Non probability convenient type of sampling technique is used. Children suffering from pneumonia between the ages 5-15 years with class III & IV on pneumonia severity index. Both genders are included under study. Patients on 2nd & 3rd generation anti-biotic therapy for pneumonia are included in the study. Children with musculoskeletal disorders, neuromuscular disorders, cardiovascular co-morbidities and children with diagnosed lobular pneumonia will be excluded. Self-structured questionnaire will be used which includes the demographics, Pneumonia Severity Index, type of Assistive Breathing devices/ Litre of Oxygen support, Vitals, Atrial blood gases(ABG's), Chest X rays and Pediatric Early Warning Sign-Respiratory system.
Detailed Description
Pneumonia is the number one infectious killer of children under age 5 globally, according to a World Health Organization (WHO) report year 2015, about 9,35,002 children die of pneumonia every year. In the same report it is stated that Pakistan ranks at third among 15 countries contributing to the global burden of child pneumonia. Pneumonia is basically an infection in one or both lungs. It can be caused by bacteria, viruses, or fungi. Bacterial pneumonia is the most common type in infants however in children Respiratory Syncytial Virus (RSV) is most common cause of Viral Pneumonia. Regarding the pathophysiology of Pneumonia, there is an inflammation in the air sacs of lungs, which are called alveoli, resultantly the alveoli are filled with fluid or pus, making it difficult for the patient to breathe. In order to clear the airways assistive techniques are used besides standard airway management. Autogenic drainage (AD) is an airway clearance technique which utilizes controlled breathing at different lung volumes in order to loosen, mobilize and move secretions in three stages towards the larger central airways.One of the modified form of Autogenic Drainage is Assisted Autogenic Drainage (AAD) which is based upon the principles of Autogenic Drainage and is used in infants and younger patient groups. This technique is performed by placing the hands on the child's chest, the therapist manually increases the expiratory flow in order to achieve the different lung volume breathing. The chapter 07: vol 1 of book "Physiotherapy Intervention" states that the aim of AAD is to achieve an optimal expiratory flow progressively through all generations of bronchi without causing dynamic airway collapse. In 2007 on " Forced expiratory technique, directed cough and autogenic drainage" and sates that these techniques in combined manner are effective in producing significant results.The direct method of chest percussion was first described by Auenbrugger as reported by the European Respiratory Journal, later it was used globally. The Chochrane Library published a research review on Chest physiotherapy for pneumonia in children in 2012, stating that Autogenic drainage is effective in treating cystic fibrosis (CF). In March 2017 on " The use of assisted autogenic drainage in children with acute and chronic respiratory disease" in population of South Africa which states that AAD is of significance importance while treating chronic respiratory diseases however the efficacy in direct effect on acute respiratory diseases is not studied before.In 1998 conducted a study on the topic of "Alternatives to percussion and postural drainage: A review of mucus clearance therapies: AD, positive expiratory pressure (PEP), Flutter valve, Intrapulmonary percussive ventilation and high frequency with Thira vest." Since late 1990's work has continuously been done on chronic respiratory diseases like Cystic Fibrosis in relation with Autogenic Drainage however regarding Assisted Autogenic Drainage in children suffering from Pneumonia, there is not much work done according to my knowledge. A study conducted in March 2017 in population of South Africa which states that AAD is of significance importance while treating chronic respiratory diseases however the efficacy in direct effect on acute respiratory diseases is not studied before. This study will be going to add Evidence Based Treatment in the practice of Cardiopulmonary Rehabilitation and could be effective treatment of Pneumonia in Children population through Assisted Autogenic Drainage technique of chest clearance. It will be helpful in treating children suffering from Pneumonia by adding literature using an evidence based Chest Physical therapy treatment. According to the consort guidelines of the assessment of manuscript the only limitation found in the parent study was that the study title included both infants and young children however only infants were actually recruited in the study. The objective of my current study is to determine the effects of Assisted Autogenic Drainage in children with pneumonia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia Childhood
Keywords
Pneumonia, Drainage, Autogenic Drainage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Assistive Autogenic Drainage
Arm Type
Experimental
Arm Description
Autogenic drainage (AD) is a breathing technique that uses controlled breathing and least amount of coughing to clear secretions from your chest. It involves you hearing and feeling your secretions as you breathe out and controlling the urge to cough until secretions are high up and easily cleared with little effort.
Intervention Type
Other
Intervention Name(s)
Assistive autogenic Drainage
Intervention Description
Assistive autogenic Drainage : All the 3 components of Autogenic drainage was given passively to the patients. By placing the hands on the child's chest, the therapist manually increases the expiratory flow to achieve the different lung volume breathing.
Primary Outcome Measure Information:
Title
Atrial Blood Gases
Description
change from baseline Atrial Blood Gases (PH, carbon dioxide partial pressure (PCO2), partial pressure of Oxygen PO2, saturation SPO2)
Time Frame
Day 07
Secondary Outcome Measure Information:
Title
Pulse rate
Description
change from baseline pulse rate
Time Frame
Day 1
Title
Pulse rate
Description
change from day 1 pulse rate
Time Frame
Day 3
Title
Pulse rate
Description
change from day 3 pulse rate
Time Frame
Day 7
Title
Respiratory
Description
change from baseline Respiratory rate
Time Frame
Day 1
Title
Respiratory
Description
change from day 1 Respiratory rate
Time Frame
Day 3
Title
Respiratory
Description
change from day 3 Respiratory rate
Time Frame
Day 7
Title
Chest Xray
Description
change of chest Xrays From baseline
Time Frame
Day 7
Title
Pediatric Early Warning System (PEWS)
Description
change of PEWs from baseline
Time Frame
Day 1
Title
Pediatric Early Warning System (PEWS)
Description
change of PEWs from day 1
Time Frame
Day 3
Title
Pediatric Early Warning System (PEWS)
Description
change of PEWs from day 3
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: class III & IV on pneumonia severity index. Both genders are included under study. Patients on 2nd & 3rd generation anti-biotic therapy for pneumonia are included. Exclusion Criteria: Children with Musculoskeletal, Neuromuscular and Cardiovascular co-morbidities. Children with diagnosed lobular pneumonia are also excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumaiyah Obaid, MSPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fauji Foundation Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19772545
Citation
Chisti MJ, Tebruegge M, La Vincente S, Graham SM, Duke T. Pneumonia in severely malnourished children in developing countries - mortality risk, aetiology and validity of WHO clinical signs: a systematic review. Trop Med Int Health. 2009 Oct;14(10):1173-89. doi: 10.1111/j.1365-3156.2009.02364.x.
Results Reference
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PubMed Identifier
15802164
Citation
Alcon A, Fabregas N, Torres A. Pathophysiology of pneumonia. Clin Chest Med. 2005 Mar;26(1):39-46. doi: 10.1016/j.ccm.2004.10.013.
Results Reference
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PubMed Identifier
10624775
Citation
Pryor JA. Physiotherapy for airway clearance in adults. Eur Respir J. 1999 Dec;14(6):1418-24. doi: 10.1183/09031936.99.14614189.
Results Reference
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PubMed Identifier
29596479
Citation
Wallaert E, Perez T, Prevotat A, Reychler G, Wallaert B, Le Rouzic O. The immediate effects of a single autogenic drainage session on ventilatory mechanics in adult subjects with cystic fibrosis. PLoS One. 2018 Mar 29;13(3):e0195154. doi: 10.1371/journal.pone.0195154. eCollection 2018.
Results Reference
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PubMed Identifier
28722167
Citation
Corten L, Jelsma J, Human A, Rahim S, Morrow BM. Assisted autogenic drainage in infants and young children hospitalized with uncomplicated pneumonia, a pilot study. Physiother Res Int. 2018 Jan;23(1). doi: 10.1002/pri.1690. Epub 2017 Jul 19.
Results Reference
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Citation
Abdelbasset W, Elnegamy T. Effect of chest physical therapy on pediatrics hospitalized with pneumonia. International Journal of Health and Rehabilitation Sciences. 2015;4(4):219-26.
Results Reference
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Citation
Agostini P, Knowles N. Autogenic drainage: the technique, physiological basis and evidence. Physiotherapy. 2007 Jun 1;93(2):157-63.
Results Reference
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PubMed Identifier
24057988
Citation
Chaves GS, Fregonezi GA, Dias FA, Ribeiro CT, Guerra RO, Freitas DA, Parreira VF, Mendonca KM. Chest physiotherapy for pneumonia in children. Cochrane Database Syst Rev. 2013 Sep 20;(9):CD010277. doi: 10.1002/14651858.CD010277.pub2.
Results Reference
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PubMed Identifier
20308222
Citation
Akre M, Finkelstein M, Erickson M, Liu M, Vanderbilt L, Billman G. Sensitivity of the pediatric early warning score to identify patient deterioration. Pediatrics. 2010 Apr;125(4):e763-9. doi: 10.1542/peds.2009-0338. Epub 2010 Mar 22.
Results Reference
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Citation
Monaghan A. Detecting and managing deterioration in children. Paediatr Nurs. 2005 Feb;17(1):32-5. doi: 10.7748/paed2005.02.17.1.32.c964. No abstract available.
Results Reference
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Citation
Fleming S, Thompson M, Stevens R, Heneghan C, Pluddemann A, Maconochie I, Tarassenko L, Mant D. Normal ranges of heart rate and respiratory rate in children from birth to 18 years of age: a systematic review of observational studies. Lancet. 2011 Mar 19;377(9770):1011-8. doi: 10.1016/S0140-6736(10)62226-X.
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Effect of Assisted Autogenic Drainage In Children Suffering From Pneumonia

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