Clinical trial NCT03742648: The Effectiveness of Deep Breathing Exercises and Incentive Spirometry in Second Degree Inhalation Burn Patients
Official title: The Effectiveness of Deep Breathing Exercises in Second Degree Inhalational Burns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn Patients
Keywords: pO2
pCO2
pH
Rhonchi
Wheeze
Crackles
ISM
DBE
Lead sponsor: Isra University
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two or more groups in parallel for the duration of the study
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Changes in values of Arterial Blood gases- pH
timeFrame: On day 01 and on day 07
measure: Changes in values of Arterial Blood Gases-pO2
timeFrame: On day 01 and on day 07
measure: Changes in values of Arterial Blood Gases- pCO2
timeFrame: On day 01 and on day 07
Secondary outcomes:
measure: Changes in Respiratory distress score(lag=0,normal=1, lead=2)
timeFrame: On day 01 and on day 07
measure: Change in Chest status/auscultation
timeFrame: On day 01 and on day 07
measure: Change in Vital signs
timeFrame: On day 01 and on day 07
measure: Change in Pulse rate
timeFrame: On day 01 and on day 07
measure: Change in Respiratory rate
timeFrame: On day 01 and on day 07
measure: Change in Blood pressure
timeFrame: On day 01 and on day 07
measure: Change in SaO2
timeFrame: On day 01 and on day 07
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Summyia Siddique Malik
state: Punjab
Study officials:
affiliation: Isra University Islamabad Campus
name: Waqar A Awan, PhD
role: STUDY_CHAIR
References:
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.