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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742648
Recruitment Status : Completed
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Isra University

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.

Condition or disease Intervention/treatment Phase
Burn Patients Other: Physiotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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
Primary Purpose: Prevention
Official Title: The Effectiveness of Deep Breathing Exercises in Second Degree Inhalational Burns
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Chest physiotherapy




Primary Outcome Measures :
  1. Changes in values of Arterial Blood gases- pH [ Time Frame: On day 01 and on day 07 ]
    Standard values taken as pH= 7.34-7.35

  2. Changes in values of Arterial Blood Gases-pO2 [ Time Frame: On day 01 and on day 07 ]
    Standard values taken as pO2= 88-100 mmHg

  3. Changes in values of Arterial Blood Gases- pCO2 [ Time Frame: On day 01 and on day 07 ]
    Standard values taken as pCO2= 45-55 mmHg


Secondary Outcome Measures :
  1. Changes in Respiratory distress score(lag=0,normal=1, lead=2) [ Time Frame: On day 01 and on day 07 ]
    Chest movement, Intercostal retractions, Xiphoid retractions, Nasal flaring, Expiratory grunt

  2. Change in Chest status/auscultation [ Time Frame: On day 01 and on day 07 ]
    Wheeze, Rhonchi, Crackles

  3. Change in Vital signs [ Time Frame: On day 01 and on day 07 ]
    Temperature

  4. Change in Pulse rate [ Time Frame: On day 01 and on day 07 ]
    Pulse rate per minute

  5. Change in Respiratory rate [ Time Frame: On day 01 and on day 07 ]
    Respiratory rate per minute

  6. Change in Blood pressure [ Time Frame: On day 01 and on day 07 ]
    Blood pressure in mmHg

  7. Change in SaO2 [ Time Frame: On day 01 and on day 07 ]
    Oxygen saturation in %



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742648


Locations
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Pakistan
Summyia Siddique Malik
Rawalpindi, Punjab, Pakistan, 46000
Sponsors and Collaborators
Isra University
Investigators
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Study Chair: Waqar A Awan, PhD Isra University Islamabad Campus
Publications of Results:
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Responsible Party: Isra University
ClinicalTrials.gov Identifier: NCT03742648    
Other Study ID Numbers: 1502-PDPT-005
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Can be shared purposefully

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Isra University:
pO2
pCO2
pH
Rhonchi
Wheeze
Crackles
ISM
DBE
Additional relevant MeSH terms:
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Burns
Wounds and Injuries