Burn PatientsRCTNCT03742648
The Effectiveness of Deep Breathing Exercises and Incentive Spirometry in Second Degree Inhalation Burn Patients
A study testing Physiotherapy in people with Burn Patients, run by Isra University at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Burn Patients
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2017to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Deep Breathing Exercises in Second Degree Inhalational Burns
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.
Read the 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.
- Conditions
- Burn Patients
- Being tested
- Physiotherapy
- Keywords
- pO2, pCO2, pH, Rhonchi, Wheeze, Crackles, ISM, DBE
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Also called Chest physiotherapy
Chest physiotherapy in burn patients in order to treat and prevent post burn respiratory complications like pneumonia etc
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in values of Arterial Blood gases- pH
Standard values taken as pH= 7.34-7.35
Measured: On day 01 and on day 07
Changes in values of Arterial Blood Gases-pO2
Standard values taken as pO2= 88-100 mmHg
Measured: On day 01 and on day 07
Changes in values of Arterial Blood Gases- pCO2
Standard values taken as pCO2= 45-55 mmHg
Measured: On day 01 and on day 07
Secondary outcomes (7)
Changes in Respiratory distress score(lag=0,normal=1, lead=2)
Chest movement, Intercostal retractions, Xiphoid retractions, Nasal flaring, Expiratory grunt
Measured: On day 01 and on day 07
Change in Chest status/auscultation
Wheeze, Rhonchi, Crackles
Measured: On day 01 and on day 07
Change in Vital signs
Temperature
Measured: On day 01 and on day 07
Change in Pulse rate
Pulse rate per minute
Measured: On day 01 and on day 07
Change in Respiratory rate
Respiratory rate per minute
Measured: On day 01 and on day 07
Change in Blood pressure
Blood pressure in mmHg
Measured: On day 01 and on day 07
Change in SaO2
Oxygen saturation in %
Measured: On day 01 and on day 07
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start1 Dec 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burn PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isra University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Waqar A Awan, PhD, Study chair, Isra University Islamabad Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742648
- Sponsor's protocol ID
- 1502-PDPT-005
- Acronym
- RCT
- Status last verified
- Nov 2018
- First submitted
- 25 Oct 2018
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Can be shared purposefully
Publications
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.
PubMed 12936906
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Deep Breathing Exercises in Second Degree Inhalational Burns
- ClinicalTrials.gov ID
- NCT03742648
- Acronym / sponsor ID
- RCT / 1502-PDPT-005
- Conditions
- Burn Patients
- Keywords
- pO2, pCO2, pH, Rhonchi, Wheeze, Crackles, ISM, DBE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Isra UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Control physiotherapy group | Active comparator | Other: PhysiotherapyBasic 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 |
| Experimental physiotherapy group | Experimental | Other: PhysiotherapyBasic 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 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapyAlso: Chest physiotherapyChest physiotherapy in burn patients in order to treat and prevent post burn respiratory complications like pneumonia etc | Other | Control physiotherapy group, Experimental physiotherapy group |
Primary outcome
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
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
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
7 secondary outcomes
Changes in Respiratory distress score(lag=0,normal=1, lead=2)
Time frame: On day 01 and on day 07
Change in Chest status/auscultation
Time frame: On day 01 and on day 07
Change in Vital signs
Time frame: On day 01 and on day 07
Change in Pulse rate
Time frame: On day 01 and on day 07
Change in Respiratory rate
Time frame: On day 01 and on day 07
Change in Blood pressure
Time frame: On day 01 and on day 07
Change in SaO2
Time frame: On day 01 and on day 07
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Results publication: PubMed 12936906Cox 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.
- Individual participant dataSharing planned: Undecided. Can be shared purposefully
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waqar A Awan, PhD study chair
Isra University Islamabad Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Burn Patients, run by Isra University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in values of Arterial Blood gases- pH (time frame: On day 01 and on day 07). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03742648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.