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NCT Number: NCT03742648

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

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.

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Key information

Conditions

Burn Patients Pathological Conditions, Signs and Symptoms Respiratory Sounds Signs and Symptoms Signs and Symptoms, Respiratory

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Summyia Siddique Malik

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physiotherapy

Other

Chest physiotherapy in burn patients in order to treat and prevent post burn respiratory complications like pneumonia etc

Other names: Chest physiotherapy

Primary outcomes

  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 outcomes

  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 %

Sponsors and collaborators

Lead sponsor

Isra University

Other

Registry information

Official study title

The Effectiveness of Deep Breathing Exercises in Second Degree Inhalational Burns

Acronym: RCT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 15, 2018
Registry last updated
Nov 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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