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

NCT ID: NCT05321888

Last Updated: 2023-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2022-10-31

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mechanical Ventilation

Mechanical Ventilation

Group Type: ACTIVE_COMPARATOR

Mechanical Ventilation

Intervention Type: OTHER

Standard Protocol

Mechanical Ventilation with Postural drainage

Mechanical Ventilation with Postural drainage

Group Type: EXPERIMENTAL

Mechanical Ventilation with Postural drainage

Intervention Type: OTHER

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

Interventions

Mechanical Ventilation

Standard Protocol

Intervention Type: OTHER

Mechanical Ventilation with Postural drainage

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sidra Afzal, PP-DPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Jinnah Burn & Reconstructive Surgery Centre

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 28149245 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22379259 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21321657 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22797452 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20859490 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

REC/RCR & AHS/220310

Identifier Type: -

Identifier Source: org_study_id