Effect of Assisted Autogenic Drainage In Children Suffering From Pneumonia

• ClinicalTrials.gov Identifier: NCT03710759
• Recruitment Status: Not yet recruiting
• First Posted: October 18, 2018
• Last Update Posted: October 18, 2018
• Sponsor: Riphah International University
• Information provided by (Responsible Party): Imran Amjad, Riphah International University

Tracking Information

• First Submitted Date: October 13, 2018
• First Posted Date: October 18, 2018
• Last Update Posted Date: October 18, 2018
• Estimated Study Start Date: November 2018
• Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 17, 2018)

Atrial Blood Gases [ Time Frame: Day 07 ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 17, 2018)

• Pulse rate [ Time Frame: Day 1 ]
  change from baseline pulse rate
• Pulse rate [ Time Frame: Day 3 ]
  change from day 1 pulse rate
• Pulse rate [ Time Frame: Day 7 ]
  change from day 3 pulse rate
• Respiratory [ Time Frame: Day 1 ]
  change from baseline Respiratory rate
• Respiratory [ Time Frame: Day 3 ]
  change from day 1 Respiratory rate
• Respiratory [ Time Frame: Day 7 ]
  change from day 3 Respiratory rate
• Chest Xray [ Time Frame: Day 7 ]
  change of chest Xrays From baseline
• Pediatric Early Warning System (PEWS) [ Time Frame: Day 1 ]
  change of PEWs from baseline
• Pediatric Early Warning System (PEWS) [ Time Frame: Day 3 ]
  change of PEWs from day 1
• Pediatric Early Warning System (PEWS) [ Time Frame: Day 7 ]
  change of PEWs from day 3

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 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 RSV (Respiratory Syncytial Virus) 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. James B. Fink et.al conducted a study 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 CF. L.Corten conducted a research 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.Eb. langenderfer et.al in 1998 conducted a study on the topic of "Alternatives to percussion and postural drainage: A review of mucus clearance therapies: AD, PD, PEP, Flutter valve, Intrapulmonary percussive ventilation and HFCC 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pneumonia Childhood

Intervention

Other: Assitive autogenic Drainage

Assistive autogenic Drainge : 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.

Study Arms

Experimental: Assitive Autogenic Drainage

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: Other: Assitive autogenic Drainage

Publications *

• 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.
• Alcón A, Fàbregas N, Torres A. Pathophysiology of pneumonia. Clin Chest Med. 2005 Mar;26(1):39-46. Review.
• Pryor JA. Physiotherapy for airway clearance in adults. Eur Respir J. 1999 Dec;14(6):1418-24. Review.
• 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.
• 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.
• 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.
• 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.
• 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.
• Monaghan A. Detecting and managing deterioration in children. Paediatr Nurs. 2005 Feb;17(1):32-5. Review.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: October 17, 2018): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2019
• Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 4 Years to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03710759
• Other Study ID Numbers: RiphahIU Summyia Siddique
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Imran Amjad, Riphah International University
• Study Sponsor: Riphah International University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Riphah International University
• Verification Date: October 2018