The Effectiveness of Deep Breathing Exercises and Incentive Spirometry in Second Degree Inhalation Burn Patients (RCT)

The Effectiveness of Deep Breathing Exercises in Second Degree Inhalational Burns

The purpose of the study was to find out the effectiveness of the Deep Breathing Exercises and Incentive Spirometry in Second degree inhalation Burn patients and to find out best effective method.It was a Randomized Control Trial performed on the patients of Pakistan Institute of Management Sciences hospital Islamabad for duration of 06 months after approval of synopsis.30 patients of second degree inhalation burns between the age of 20-50 years having good pre burn respiratory state and irrespective of gender discrimination who were currently on nasal cannula were randomly allocated in control and experimental groups.However all unconscious patients other than second degree inhalation burn and having comorbidities were excluded. The conventional treatment with steam inhalation and nebulization followed by Incentive spirometry with 10-15cycles and the treatment session lasts for 35-45 minutes for a period of 07 days with two sessions of this protocol were given to control group each day.For experimental group patients were made to perform different types of deep breathing exercises with 5-10 repetitions for a period of 07days with two sessions of this treatment protocol each day. Self structured questionnaires with informed consents were used to assess the data on day 00 and day 07 by Physiotherapist.The data was then analyzed using SPSS version 21.0.The results were then formulated using statistical analysis and then were arranged in different tables and graphs.

Study Overview

• Status: Completed
• Conditions: Burn Patients
• Intervention / Treatment: Other: Physiotherapy

Detailed Description

Objective: To find out the effectiveness of the Deep Breathing Exercises and Incentive Spirometry in Second degree inhalation Burn patients and to find out best effective method.

Study Design:It is a Randomized Control Trial. Place and Duration of Study: Data was collected from Department of Burn, Pakistan Institute of Management Sciences hospital Islamabad, the study duration is 06 months after approval of synopsis.

Methodology: A total of 30 Second degree inhalation burn patients were included. Inclusion criteria includes both genders of patients between the ages of 20 to 50 years,with good Pre-Burn respiratory state and currently on Nasal Cannula.They were then randomly allocated using lottery method in control and experimental groups. Exclusion criteria includes all unconscious patients other than second degree inhalation burn and with other comorbidities.The treatment protocol designed for control group involves conventional treatment with steam inhalation and nebulization followed by Incentive spirometry with 10-15 cycles,the treatment session lasts for 35-45 minutes for a period of 07 days with two sessions of this protocol each day.The treatment protocol for experimental group includes different types of deep breathing exercises with 5-10 repetitions for a period of 07days with two sessions of this treatment protocol each day.The data was collected through self-structured questionnaires containing 17 questions and each question has four options.Baseline data was collected on Day 00 and then on Day 07 data was recollected for comparison of both groups by Physiotherapist.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Summyia Siddique Malik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All the patients suffering from Second Degree inhalation Burn.
• Both genders will be included with good Pre-Burn respiratory state.
• All the patients after first surgical intervention, using mask and nasal cannulas, between the age of 20 - 50 years.

Exclusion Criteria:

• Patients suffering from other types of burns e.g. chemical etc.
• All the unconscious patients/ventilator dependent patients.
• All the patients with co-morbidities including COPD, Emphysema.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control physiotherapy group; Basic standard medical and nursing care along with standard chest physiotherapy involving steam inhalation and nebulization for 15-20 minutes and 10-15 cycles of incentive spirometry twice daily	Other: Physiotherapy; Chest physiotherapy in burn patients in order to treat and prevent post burn respiratory complications like pneumonia etc; Other Names: Chest physiotherapy
Experimental: Experimental physiotherapy group; Basic standard medical and nursing care along with chest physiotherapy involving any of the deep breathing exercises as per patients ease with 5-10 repetitions each, twice daily	Other: Physiotherapy; Chest physiotherapy in burn patients in order to treat and prevent post burn respiratory complications like pneumonia etc; Other Names: Chest physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in values of Arterial Blood gases- pH	Standard values taken as pH= 7.34-7.35	On day 01 and on day 07
Changes in values of Arterial Blood Gases-pO2	Standard values taken as pO2= 88-100 mmHg	On day 01 and on day 07
Changes in values of Arterial Blood Gases- pCO2	Standard values taken as pCO2= 45-55 mmHg	On day 01 and on day 07

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Respiratory distress score(lag=0,normal=1, lead=2)	Chest movement, Intercostal retractions, Xiphoid retractions, Nasal flaring, Expiratory grunt	On day 01 and on day 07
Change in Chest status/auscultation	Wheeze, Rhonchi, Crackles	On day 01 and on day 07
Change in Vital signs	Temperature	On day 01 and on day 07
Change in Pulse rate	Pulse rate per minute	On day 01 and on day 07
Change in Respiratory rate	Respiratory rate per minute	On day 01 and on day 07
Change in Blood pressure	Blood pressure in mmHg	On day 01 and on day 07
Change in SaO2	Oxygen saturation in %	On day 01 and on day 07

Collaborators and Investigators

• Sponsor: Isra University
• Investigators: Study Chair: Waqar A Awan, PhD, Isra University Islamabad Campus

Publications and helpful links

General Publications

• Cox RA, Burke AS, Soejima K, Murakami K, Katahira J, Traber LD, Herndon DN, Schmalstieg FC, Traber DL, Hawkins HK. Airway obstruction in sheep with burn and smoke inhalation injuries. Am J Respir Cell Mol Biol. 2003 Sep;29(3 Pt 1):295-302. doi: 10.1165/rcmb.4860.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): February 28, 2018

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 12, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: pH; ISM; pCO2; Wheeze; Crackles; pO2; Rhonchi; DBE
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 1502-PDPT-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Can be shared purposefully

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No