NCT03742648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

October 25, 2018

Last Update Submit

November 12, 2018

Conditions

Keywords

pO2pCO2pHRhonchiWheezeCracklesISMDBE

Outcome Measures

Primary Outcomes (3)

  • Changes in values of Arterial Blood gases- pH

    Standard values taken as pH= 7.34-7.35

    On day 01 and on day 07

  • Changes in values of Arterial Blood Gases-pO2

    Standard values taken as pO2= 88-100 mmHg

    On day 01 and on day 07

  • Changes in values of Arterial Blood Gases- pCO2

    Standard values taken as pCO2= 45-55 mmHg

    On day 01 and on day 07

Secondary Outcomes (7)

  • Changes in Respiratory distress score(lag=0,normal=1, lead=2)

    On day 01 and on day 07

  • Change in Chest status/auscultation

    On day 01 and on day 07

  • Change in Vital signs

    On day 01 and on day 07

  • Change in Pulse rate

    On day 01 and on day 07

  • Change in Respiratory rate

    On day 01 and on day 07

  • +2 more secondary outcomes

Study Arms (2)

Control physiotherapy group

ACTIVE COMPARATOR

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

Experimental physiotherapy group

EXPERIMENTAL

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

Interventions

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

Also known as: Chest physiotherapy
Control physiotherapy groupExperimental physiotherapy group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Summyia Siddique Malik

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related 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. doi: 10.1165/rcmb.4860.

MeSH Terms

Conditions

Respiratory Sounds

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Waqar A Awan, PhD

    Isra University Islamabad Campus

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
There is no party who is masked
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are assigned to one of two or more groups in parallel for the duration of the study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2018

First Posted

November 15, 2018

Study Start

December 1, 2017

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

November 15, 2018

Record last verified: 2018-11

Locations