Mechanical Ventilation With and Without Postural Drainage in Burn Patients With ARDS

NCT05321888 | Completed

• 1 other identifier: REC/RCR & AHS/220310
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns (Physical Finding)

Keywords

Respiration; Artifical Respiration; Postural drainage; Respiratory distress syndrome; Respiratory physiological phenomena

Outcome Measures

Primary Outcomes (1)

• Acute Physiology and Chronic Health Evaluation II

  APACHE stands for Acute Physiology and Chronic Health Evaluation II which is mostly used in the ICU to check the severity of the disease. This score measures the seriousness of sickness and the adequacy of clinical medical services and the doctor's decision allowing more exact prognostic delineation of seriously sick patients. APACHE II an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death The tool consists of twelve physiological variables. From which we are using five variables are age, Respiratory rate, Oxygenation (FiO2, PaO2), Mean Arterial Pressure, Glasgow comma score, Temperature, Systolic Blood Pressure, Heart Rate, Arterial pH, Acute Renal Failure, History of organ failure other than this Mechanical ventilation or CPAP, gender, and sputum profiles were also included which are not the part of this scale.

  SECOND DAY

Study Arms (2)

Mechanical Ventilation

ACTIVE COMPARATOR

Mechanical Ventilation

Other: Mechanical Ventilation

Mechanical Ventilation with Postural drainage

EXPERIMENTAL

Mechanical Ventilation with Postural drainage

Other: Mechanical Ventilation with Postural drainage

Interventions

Mechanical Ventilation OTHER

Standard Protocol

Mechanical Ventilation

Mechanical Ventilation with Postural drainage OTHER

This Group will be treated by postural drainage and mechanical ventilation for two consecutive days

Mechanical Ventilation with Postural drainage

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Jinnah Burn & Reconstructive Surgery Centre

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (6)

• 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.

  PMID: 28149245 BACKGROUND

• 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.

  PMID: 22379259 BACKGROUND

• 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.

  PMID: 21321657 BACKGROUND

• 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.

  PMID: 22797452 BACKGROUND

• 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.

  PMID: 20859490 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Burns; Respiratory Aspiration; Respiratory Distress Syndrome

Interventions

Respiration, Artificial; Drainage, Postural

Condition Hierarchy (Ancestors)

Wounds and Injuries; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy; Drainage; Physical Therapy Modalities; Rehabilitation

Study Officials

• Sidra Afzal, PP-DPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: April 11, 2022
• Study Start: January 15, 2022
• Primary Completion: September 15, 2022
• Study Completion: October 31, 2022
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)