Burns (Physical Finding)NCT05321888
Mechanical Ventilation With and Without Postural Drainage in Burn Patients With ARDS
A study testing Mechanical Ventilation and Mechanical Ventilation with Postural drainage in people with Burns (Physical Finding), run by Riphah International University at 1 site in Pakistan.
Trial summary
Inhalation injury become a more common cause of death in burn patients but alone the smoke injury has low mortality rate. It is reported that a combination of smoke injury with cutaneous burn increases the mortality rate and predispose to Acute Respiratory Distress Syndrome. Read more about this study
- Who is it for?
- Ages 10 to 40 years
- Conditions the study is for
- Burns (Physical Finding)
- What is being tested?
- Mechanical Ventilation and Mechanical Ventilation with Postural drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2022to 31 Oct 2022
- 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 10 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients of both gender male and female are included.
- Patient age should be between 10-40 years
- Patients that are on mechanical ventilation
- Patients with inhalation injury
- Patients undergo mechanical ventilation for >48 hours
Who cannot join
- Patient with no past medical history of Lung disease
- Subject with more than 80% of burn according to Rule of Nine
- Patients with cardiac instability such as recent Myocardial infarction, Unstable angina and severe hypotension and hypertension
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Jinnah Burn & Reconstructive Surgery Centre
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Mechanical Ventilation With and Without Postural Drainage on Oxygen Saturation, Airway Clearance in Burn Patients With Acute Respiratory Distress Syndrome
Inhalation injury become a more common cause of death in burn patients but alone the smoke injury has low mortality rate. It is reported that a combination of smoke injury with cutaneous burn increases the mortality rate and predispose to Acute Respiratory Distress Syndrome. This experimental study aims to report the benefits of postural drainage on the respiratory system in burn patients. This study will determine the effects of postural drainage on oxygen saturation, airway clearance in burn patients with Acute Respiratory Distress Syndrome by comparing mechanical ventilation with and without the application of postural drainage. A randomized clinical trial will be conducted in the data and will be collected from the ICU of Jinnah Burn \& Reconstructive Surgery Centre and Shafique Aziz Free Burn Centre through consecutive sampling through technique on 50 patients which will be allocated through sealed opaque enveloped into Group A and Group B. Pre and post treatment value of oxygenation and other variables for both group will be recorded by using APACHE II. Group A will be treated by postural drainage and mechanical ventilation for two consecutive days. Similarly, Group B will be treated by mechanical ventilation only. Data will be analyzed using SPSS software 25. After assessing the normality of data by the Shapiro-Wilk test, it will be decided either parametric or non-parametric tests will be used within a group or between two groups.
- Conditions
- Burns (Physical Finding)
- Being tested
- Mechanical Ventilation, Mechanical Ventilation with Postural drainage
- Keywords
- Respiration, Artifical Respiration, Postural drainage, Respiratory distress syndrome, Respiratory physiological phenomena
- Medical subject headings
- Burns, Respiratory Aspiration, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical VentilationOther
Standard Protocol
Mechanical Ventilation with Postural drainageOther
This Group will be treated by postural drainage and mechanical ventilation for two consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Ventilation | Active comparator | Mechanical Ventilation Receives: Other: Mechanical Ventilation |
| Mechanical Ventilation with Postural drainage | Experimental | Mechanical Ventilation with Postural drainage Receives: Other: Mechanical Ventilation with Postural drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Physiology and Chronic Health Evaluation II
APACHE stands for Acute Physiology and Chronic Health Evaluation II which is mostly used in the ICU to check the severity of the disease. This score measures the seriousness of sickness and the adequacy of clinical medical services and the doctor's decision allowing more exact prognostic delineation of seriously sick patients. APACHE II an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death The tool consists of twelve physiological variables. From which we are using five variables are age, Respiratory rate, Oxygenation (FiO2, PaO2), Mean Arterial Pressure, Glasgow comma score, Temperature, Systolic Blood Pressure, Heart Rate, Arterial pH, Acute Renal Failure, History of organ failure other than this Mechanical ventilation or CPAP, gender, and sputum profiles were also included which are not the part of this scale.
Measured: SECOND DAY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start15 Jan 2022
- Primary completion15 Sep 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Burns (Physical Finding)Studies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Afzal, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321888
- Sponsor's protocol ID
- REC/RCR & AHS/220310
- Status last verified
- Jan 2023
- First submitted
- 2 Apr 2022
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silva L, Garcia L, Oliveira B, Tanita M, Festti J, Cardoso L, Lavado L, Grion C. Acute respiratory distress syndrome in burn patients: incidence and risk factor analysis. Ann Burns Fire Disasters. 2016 Sep 30;29(3):178-182.
PubMed 28149245Chung F, Mueller D. Physical therapy management of ventilated patients with acute respiratory distress syndrome or severe acute lung injury. Physiother Can. 2011 Spring;63(2):191-8. doi: 10.3138/ptc.2010-10. Epub 2011 Apr 13. No abstract available.
PubMed 22379259Sharma RK, Parashar A. Special considerations in paediatric burn patients. Indian J Plast Surg. 2010 Sep;43(Suppl):S43-50. doi: 10.4103/0970-0358.70719.
PubMed 21321657ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
PubMed 22797452Pattanshetty RB, Gaude GS. Effect of multimodality chest physiotherapy in prevention of ventilator-associated pneumonia: A randomized clinical trial. Indian J Crit Care Med. 2010 Apr;14(2):70-6. doi: 10.4103/0972-5229.68218.
PubMed 20859490Cao Z. Application of Drainage Position Ventilation and Real-Time Bedside Monitoring in Mechanical Ventilation of Patients Infected with nCov-19. J Anaesth Ther. 2020;2(104):2.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mechanical Ventilation With and Without Postural Drainage on Oxygen Saturation, Airway Clearance in Burn Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT05321888
- Acronym / sponsor ID
- REC/RCR & AHS/220310
- Conditions
- Burns (Physical Finding)
- Keywords
- Respiration, Artifical Respiration, Postural drainage, Respiratory distress syndrome, Respiratory physiological phenomena
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 11 Apr 2022 (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.
Inhalation injury become a more common cause of death in burn patients but alone the smoke injury has low mortality rate. It is reported that a combination of smoke injury with cutaneous burn increases the mortality rate and predispose to Acute Respiratory Distress Syndrome. This experimental study aims to report the benefits of postural drainage on the respiratory system in burn patients. This study will determine the effects of postural drainage on oxygen saturation, airway clearance in burn patients with Acute Respiratory Distress Syndrome by comparing mechanical ventilation with and without the application of postural drainage. A randomized clinical trial will be conducted in the data and will be collected from the ICU of Jinnah Burn \& Reconstructive Surgery Centre and Shafique Aziz Free Burn Centre through consecutive sampling through technique on 50 patients which will be allocated through sealed opaque enveloped into Group A and Group B. Pre and post treatment value of oxygenation and other variables for both group will be recorded by using APACHE II. Group A will be treated by postural drainage and mechanical ventilation for two consecutive days. Similarly, Group B will be treated by mechanical ventilation only. Data will be analyzed using SPSS software 25. After assessing the normality of data by the Shapiro-Wilk test, it will be decided either parametric or non-parametric tests will be used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical Ventilation | Active comparator | Other: Mechanical VentilationMechanical Ventilation |
| Mechanical Ventilation with Postural drainage | Experimental | Other: Mechanical Ventilation with Postural drainageMechanical Ventilation with Postural drainage |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients of both gender male and female are included.
- Patient age should be between 10-40 years
- Patients that are on mechanical ventilation
- Patients with inhalation injury
- Patients undergo mechanical ventilation for >48 hours
Key exclusion criteria (3 listed)
- Patient with no past medical history of Lung disease
- Subject with more than 80% of burn according to Rule of Nine
- Patients with cardiac instability such as recent Myocardial infarction, Unstable angina and severe hypotension and hypertension
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 |
|---|---|---|
| Mechanical VentilationStandard Protocol | Other | Mechanical Ventilation |
| Mechanical Ventilation with Postural drainageThis Group will be treated by postural drainage and mechanical ventilation for two consecutive days | Other | Mechanical Ventilation with Postural drainage |
Primary outcome
Acute Physiology and Chronic Health Evaluation II
Time frame: SECOND DAY
APACHE stands for Acute Physiology and Chronic Health Evaluation II which is mostly used in the ICU to check the severity of the disease. This score measures the seriousness of sickness and the adequacy of clinical medical services and the doctor's decision allowing more exact prognostic delineation of seriously sick patients. APACHE II an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death The tool consists of twelve physiological variables. From which we are using five variables are age, Respiratory rate, Oxygenation (FiO2, PaO2), Mean Arterial Pressure, Glasgow comma score, Temperature, Systolic Blood Pressure, Heart Rate, Arterial pH, Acute Renal Failure, History of organ failure other than this Mechanical ventilation or CPAP, gender, and sputum profiles were also included which are not the part of this scale.
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 5 Jan 2023.
- Background: PubMed 28149245Silva L, Garcia L, Oliveira B, Tanita M, Festti J, Cardoso L, Lavado L, Grion C. Acute respiratory distress syndrome in burn patients: incidence and risk factor analysis. Ann Burns Fire Disasters. 2016 Sep 30;29(3):178-182.
- Background: PubMed 22379259Chung F, Mueller D. Physical therapy management of ventilated patients with acute respiratory distress syndrome or severe acute lung injury. Physiother Can. 2011 Spring;63(2):191-8. doi: 10.3138/ptc.2010-10. Epub 2011 Apr 13. No abstract available.
- Background: PubMed 21321657Sharma RK, Parashar A. Special considerations in paediatric burn patients. Indian J Plast Surg. 2010 Sep;43(Suppl):S43-50. doi: 10.4103/0970-0358.70719.
- Background: PubMed 22797452ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
- Background: PubMed 20859490Pattanshetty RB, Gaude GS. Effect of multimodality chest physiotherapy in prevention of ventilator-associated pneumonia: A randomized clinical trial. Indian J Crit Care Med. 2010 Apr;14(2):70-6. doi: 10.4103/0972-5229.68218.
- BackgroundCao Z. Application of Drainage Position Ventilation and Real-Time Bedside Monitoring in Mechanical Ventilation of Patients Infected with nCov-19. J Anaesth Ther. 2020;2(104):2.
- Individual participant dataSharing planned: No
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.
Sidra Afzal, PP-DPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Ventilation and Mechanical Ventilation with Postural drainage in people with Burns (Physical Finding), run by Riphah International 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 5 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 5 Jan 2023. 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?
Acute Physiology and Chronic Health Evaluation II (time frame: SECOND DAY). 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 NCT05321888, which also lists 6 linked publications.
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 5 Jan 2023.