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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03742648
Other study ID # 1502-PDPT-005
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2017
Est. completion date February 28, 2018

Study information

Verified date November 2018
Source Isra University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 28, 2018
Est. primary completion date February 28, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Pakistan Summyia Siddique Malik Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Isra University

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in values of Arterial Blood gases- pH Standard values taken as pH= 7.34-7.35 On day 01 and on day 07
Primary Changes in values of Arterial Blood Gases-pO2 Standard values taken as pO2= 88-100 mmHg On day 01 and on day 07
Primary Changes in values of Arterial Blood Gases- pCO2 Standard values taken as pCO2= 45-55 mmHg On day 01 and on day 07
Secondary 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
Secondary Change in Chest status/auscultation Wheeze, Rhonchi, Crackles On day 01 and on day 07
Secondary Change in Vital signs Temperature On day 01 and on day 07
Secondary Change in Pulse rate Pulse rate per minute On day 01 and on day 07
Secondary Change in Respiratory rate Respiratory rate per minute On day 01 and on day 07
Secondary Change in Blood pressure Blood pressure in mmHg On day 01 and on day 07
Secondary Change in SaO2 Oxygen saturation in % On day 01 and on day 07
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