Clinical trial NCT05321888: Mechanical Ventilation With and Without Postural Drainage in Burn Patients With ARDS
Official title: Effects of Mechanical Ventilation With and Without Postural Drainage on Oxygen Saturation, Airway Clearance in Burn Patients With Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns (Physical Finding)
Keywords: Respiration
Artifical Respiration
Postural drainage
Respiratory distress syndrome
Respiratory physiological phenomena
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Inhalation injury become a more common cause of death in burn patients but alone the smoke injury has low mortality rate. It is reported that a combination of smoke injury with cutaneous burn increases the mortality rate and predispose to Acute Respiratory Distress Syndrome. This experimental study aims to report the benefits of postural drainage on the respiratory system in burn patients. This study will determine the effects of postural drainage on oxygen saturation, airway clearance in burn patients with Acute Respiratory Distress Syndrome by comparing mechanical ventilation with and without the application of postural drainage. A randomized clinical trial will be conducted in the data and will be collected from the ICU of Jinnah Burn \& Reconstructive Surgery Centre and Shafique Aziz Free Burn Centre through consecutive sampling through technique on 50 patients which will be allocated through sealed opaque enveloped into Group A and Group B. Pre and post treatment value of oxygenation and other variables for both group will be recorded by using APACHE II. Group A will be treated by postural drainage and mechanical ventilation for two consecutive days. Similarly, Group B will be treated by mechanical ventilation only. Data will be analyzed using SPSS software 25. After assessing the normality of data by the Shapiro-Wilk test, it will be decided either parametric or non-parametric tests will be used within a group or between two groups.


Eligibility criteria: Inclusion Criteria:

* Patients of both gender male and female are included.
* Patient age should be between 10-40 years
* Patients that are on mechanical ventilation
* Patients with inhalation injury
* Patients undergo mechanical ventilation for \>48 hours

Exclusion Criteria:

* Patient with no past medical history of Lung disease
* Subject with more than 80% of burn according to Rule of Nine
* Patients with cardiac instability such as recent Myocardial infarction, Unstable angina and severe hypotension and hypertension

Primary outcomes:
measure: Acute Physiology and Chronic Health Evaluation II
timeFrame: SECOND DAY
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Jinnah Burn & Reconstructive Surgery Centre
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sidra Afzal, PP-DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silva L, Garcia L, Oliveira B, Tanita M, Festti J, Cardoso L, Lavado L, Grion C. Acute respiratory distress syndrome in burn patients: incidence and risk factor analysis. Ann Burns Fire Disasters. 2016 Sep 30;29(3):178-182.
citation: Chung F, Mueller D. Physical therapy management of ventilated patients with acute respiratory distress syndrome or severe acute lung injury. Physiother Can. 2011 Spring;63(2):191-8. doi: 10.3138/ptc.2010-10. Epub 2011 Apr 13. No abstract available.
citation: Sharma RK, Parashar A. Special considerations in paediatric burn patients. Indian J Plast Surg. 2010 Sep;43(Suppl):S43-50. doi: 10.4103/0970-0358.70719.
citation: ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
citation: Pattanshetty RB, Gaude GS. Effect of multimodality chest physiotherapy in prevention of ventilator-associated pneumonia: A randomized clinical trial. Indian J Crit Care Med. 2010 Apr;14(2):70-6. doi: 10.4103/0972-5229.68218.
citation: Cao Z. Application of Drainage Position Ventilation and Real-Time Bedside Monitoring in Mechanical Ventilation of Patients Infected with nCov-19. J Anaesth Ther. 2020;2(104):2.