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Completed

NCT Number: NCT05321888

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

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.

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Key information

Age range

10 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinnah Burn & Reconstructive Surgery Centre

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical ventilation

Other

Standard Protocol

Mechanical Ventilation with Postural drainage

Other

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

Primary outcomes

  1. Acute Physiology and Chronic Health Evaluation II

    Time frame: SECOND DAY

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Mechanical Ventilation With and Without Postural Drainage on Oxygen Saturation, Airway Clearance in Burn Patients With Acute Respiratory Distress Syndrome

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 11, 2022
Registry last updated
Jan 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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