Mechanical Ventilation With and Without Postural Drainage in Burn Patients With ARDS
Primary Purpose
Burns (Physical Finding)
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mechanical Ventilation
Mechanical Ventilation with Postural drainage
Sponsored by
About this trial
This is an interventional treatment trial for Burns (Physical Finding) focused on measuring Respiration, Artifical Respiration, Postural drainage, Respiratory distress syndrome, Respiratory physiological phenomena
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
Sites / Locations
- Jinnah Burn & Reconstructive Surgery Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Mechanical Ventilation
Mechanical Ventilation with Postural drainage
Arm Description
Mechanical Ventilation
Mechanical Ventilation with Postural drainage
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05321888
First Posted
April 2, 2022
Last Updated
January 4, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05321888
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns (Physical Finding)
Keywords
Respiration, Artifical Respiration, Postural drainage, Respiratory distress syndrome, Respiratory physiological phenomena
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mechanical Ventilation
Arm Type
Active Comparator
Arm Description
Mechanical Ventilation
Arm Title
Mechanical Ventilation with Postural drainage
Arm Type
Experimental
Arm Description
Mechanical Ventilation with Postural drainage
Intervention Type
Other
Intervention Name(s)
Mechanical Ventilation
Intervention Description
Standard Protocol
Intervention Type
Other
Intervention Name(s)
Mechanical Ventilation with Postural drainage
Intervention Description
This Group will be treated by postural drainage and mechanical ventilation for two consecutive days
Primary Outcome Measure Information:
Title
Acute Physiology and Chronic Health Evaluation II
Description
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.
Time Frame
SECOND DAY
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidra Afzal, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah Burn & Reconstructive Surgery Centre
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28149245
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.
Results Reference
background
PubMed Identifier
22379259
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.
Results Reference
background
PubMed Identifier
21321657
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.
Results Reference
background
PubMed Identifier
22797452
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.
Results Reference
background
PubMed Identifier
20859490
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.
Results Reference
background
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.
Results Reference
background
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Mechanical Ventilation With and Without Postural Drainage in Burn Patients With ARDS
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