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

Primary Purpose

Burn Patients

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
Isra University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Burn Patients focused on measuring pO2, pCO2, pH, Rhonchi, Wheeze, Crackles, ISM, DBE

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Summyia Siddique Malik

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control physiotherapy group

Experimental physiotherapy group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in values of Arterial Blood gases- pH
Standard values taken as pH= 7.34-7.35
Changes in values of Arterial Blood Gases-pO2
Standard values taken as pO2= 88-100 mmHg
Changes in values of Arterial Blood Gases- pCO2
Standard values taken as pCO2= 45-55 mmHg

Secondary Outcome Measures

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

Full Information

First Posted
October 25, 2018
Last Updated
November 12, 2018
Sponsor
Isra University
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1. Study Identification

Unique Protocol Identification Number
NCT03742648
Brief Title
The Effectiveness of Deep Breathing Exercises and Incentive Spirometry in Second Degree Inhalation Burn Patients
Acronym
RCT
Official Title
The Effectiveness of Deep Breathing Exercises in Second Degree Inhalational Burns
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Isra University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Patients
Keywords
pO2, pCO2, pH, Rhonchi, Wheeze, Crackles, ISM, DBE

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of two or more groups in parallel for the duration of the study
Masking
None (Open Label)
Masking Description
There is no party who is masked
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control physiotherapy group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Experimental physiotherapy group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Other Intervention Name(s)
Chest physiotherapy
Intervention Description
Chest physiotherapy in burn patients in order to treat and prevent post burn respiratory complications like pneumonia etc
Primary Outcome Measure Information:
Title
Changes in values of Arterial Blood gases- pH
Description
Standard values taken as pH= 7.34-7.35
Time Frame
On day 01 and on day 07
Title
Changes in values of Arterial Blood Gases-pO2
Description
Standard values taken as pO2= 88-100 mmHg
Time Frame
On day 01 and on day 07
Title
Changes in values of Arterial Blood Gases- pCO2
Description
Standard values taken as pCO2= 45-55 mmHg
Time Frame
On day 01 and on day 07
Secondary Outcome Measure Information:
Title
Changes in Respiratory distress score(lag=0,normal=1, lead=2)
Description
Chest movement, Intercostal retractions, Xiphoid retractions, Nasal flaring, Expiratory grunt
Time Frame
On day 01 and on day 07
Title
Change in Chest status/auscultation
Description
Wheeze, Rhonchi, Crackles
Time Frame
On day 01 and on day 07
Title
Change in Vital signs
Description
Temperature
Time Frame
On day 01 and on day 07
Title
Change in Pulse rate
Description
Pulse rate per minute
Time Frame
On day 01 and on day 07
Title
Change in Respiratory rate
Description
Respiratory rate per minute
Time Frame
On day 01 and on day 07
Title
Change in Blood pressure
Description
Blood pressure in mmHg
Time Frame
On day 01 and on day 07
Title
Change in SaO2
Description
Oxygen saturation in %
Time Frame
On day 01 and on day 07

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waqar A Awan, PhD
Organizational Affiliation
Isra University Islamabad Campus
Official's Role
Study Chair
Facility Information:
Facility Name
Summyia Siddique Malik
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Can be shared purposefully
Citations:
PubMed Identifier
12936906
Citation
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.
Results Reference
result

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

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