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

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05321888
Collaborator
(none)
50
1
2
9.5
5.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mechanical Ventilation
  • Other: Mechanical Ventilation with Postural drainage
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Mechanical Ventilation With and Without Postural Drainage on Oxygen Saturation, Airway Clearance in Burn Patients With Acute Respiratory Distress Syndrome
Actual Study Start Date :
Jan 15, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Mechanical Ventilation

Mechanical Ventilation

Other: Mechanical Ventilation
Standard Protocol

Experimental: Mechanical Ventilation with Postural drainage

Mechanical Ventilation with Postural drainage

Other: Mechanical Ventilation with Postural drainage
This Group will be treated by postural drainage and mechanical ventilation for two consecutive days

Outcome Measures

Primary Outcome Measures

  1. Acute Physiology and Chronic Health Evaluation II [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jinnah Burn & Reconstructive Surgery Centre Lahore Punjab Pakistan 54000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Sidra Afzal, PP-DPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05321888
Other Study ID Numbers:
  • REC/RCR & AHS/220310
First Posted:
Apr 11, 2022
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2022