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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03710759
Other study ID # REC Summyia Siddique
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date June 10, 2019

Study information

Verified date September 2020
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 10, 2019
Est. primary completion date May 30, 2019
Accepts healthy volunteers No
Gender All
Age group 4 Years to 12 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Assistive autogenic Drainage
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.

Locations

Country Name City State
Pakistan Fauji Foundation Hospital Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (12)

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.

Agostini P, Knowles N. Autogenic drainage: the technique, physiological basis and evidence. Physiotherapy. 2007 Jun 1;93(2):157-63.

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. — View Citation

Alcón A, Fàbregas N, Torres A. Pathophysiology of pneumonia. Clin Chest Med. 2005 Mar;26(1):39-46. Review. — View 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. Review. Update in: Cochrane Database Syst Rev. 2019 Jan 02;1:CD010277. — View 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. Review. — View 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. — View Citation

Fleming S, Thompson M, Stevens R, Heneghan C, Plüddemann 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. Review. — View Citation

Gajdos V, Katsahian S, Beydon N, Abadie V, de Pontual L, Larrar S, Epaud R, Chevallier B, Bailleux S, Mollet-Boudjemline A, Bouyer J, Chevret S, Labrune P. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial. PLoS Med. 2010 Sep 28;7(9):e1000345. doi: 10.1371/journal.pmed.1000345. — View Citation

Monaghan A. Detecting and managing deterioration in children. Paediatr Nurs. 2005 Feb;17(1):32-5. Review. — View Citation

Pryor JA. Physiotherapy for airway clearance in adults. Eur Respir J. 1999 Dec;14(6):1418-24. Review. — View 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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Atrial Blood Gases change from baseline Atrial Blood Gases (PH, carbon dioxide partial pressure (PCO2), partial pressure of Oxygen PO2, saturation SPO2) Day 07
Secondary Pulse rate change from baseline pulse rate Day 1
Secondary Pulse rate change from day 1 pulse rate Day 3
Secondary Pulse rate change from day 3 pulse rate Day 7
Secondary Respiratory change from baseline Respiratory rate Day 1
Secondary Respiratory change from day 1 Respiratory rate Day 3
Secondary Respiratory change from day 3 Respiratory rate Day 7
Secondary Chest Xray change of chest Xrays From baseline Day 7
Secondary Pediatric Early Warning System (PEWS) change of PEWs from baseline Day 1
Secondary Pediatric Early Warning System (PEWS) change of PEWs from day 1 Day 3
Secondary Pediatric Early Warning System (PEWS) change of PEWs from day 3 Day 7
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