Inhalation InjuryNCT05190497
Effects of IMT on Pulmonary Functions IN CASES With Inhalation Injury
A study testing Exercise group in people with Inhalation Injury and Pulmonary Function, run by Cairo University at 1 site in Egypt.
Trial summary
The current study aimed to investigate the effect of inspiratory muscle training (IMT) on pulmonary functions (FEV1and FVC), and respiratory muscle strength in patients with inhalation injury, which may prove to be a promising intervention helping to improve exercise tolerance, relieve dyspnea and suggests an… Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Inhalation Injury, Pulmonary Function, Respiratory Muscle Strength
- What is being tested?
- Exercise group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2021to 28 Feb 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 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male patients suffering from inhalation injury.
- Participant age ranged from 20-35 years old.
- All patients had the same medical care.
- Participants have received a good explanation of the treatment and measurement device.
- Treatment was conducted one month after inhalation injury.
Who cannot join
- Patients were excluded from this study for any of the following cases such as
- Instability of patient's medical condition.
- Presence of any diseases that could affect the study results.
- Participants having respiratory, cardiac, or neurological diseases that affect pulmonary functions.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Khaled Takey Ahmed
Giza
0201115586016, khaled.takey@must.edu.eg
About this study
Official title: Effects of Inspiratory Muscle Training on Clinical Predictors of Respiratory Muscle Strength and Lung Function in Burned Patients With Inhalation Injury
The current study aimed to investigate the effect of inspiratory muscle training (IMT) on pulmonary functions (FEV1and FVC), and respiratory muscle strength in patients with inhalation injury, which may prove to be a promising intervention helping to improve exercise tolerance, relieve dyspnea and suggests an improvement in respiratory muscle function.
Read the detailed description
Forty male patients suffering from inhalation injury were been included in this study, Participants' ages ranged from 20-35 years old. Patients were selected from the burn department, Om El-Masreen hospital, and randomly assigned into two equal groups.
The exercise group received inspiratory muscle training in addition to routine chest physiotherapy in the form of (deep breathing, coughing, and early ambulation) three times per week for four weeks (group A). The Control group received only routine chest physiotherapy (group B). This study obtained ethical approval by the institutional review board of the Faculty of Physical Therapy - Cairo University, with reference number: P.T.REC/012/003431
- Being tested
- Exercise group
- Keywords
- INSPIRATORT TRAINING -INHALATION INJURY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise groupDevice
Also called INSPIRATORY MUSCLE TRAINING
Maximal respiratory pressure and reflecting muscles strength were measured by a mouth pressure meter
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | inspiratory muscle training in addition to routine chest physiotherapy in the form of (deep breathing, coughing, and early ambulation) Receives: Device: Exercise group |
| control | No intervention | The Control group received only routine chest physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PULMONARY FUNCTION TEST
Each patient's weight in kilograms, and height in meters were recorded and entered the machine. An individual sat in a chair and inhaled deeply before closing their mouth tightly around the tube. Several exercises were carried out until the patient comprehended and was comfortable with the instruction. The patient inhaled deeply and exhaled as quickly as possible into the spirometer(Morgan Trans Flow Test Vicatest p2 (Kent, ME 87 ED, England).
Measured: 3 MONTHS
Respiratory muscles Strength Measurement
Maximal respiratory pressure and reflecting muscles strength were measured by a mouth pressure meter (Pony FX; COSMED, Rome, Italy) in the sitting position. The highest maximal expiratory pressure (MEP) in cmH2O, and maximal inspiratory pressure (MIP) in cmH2O values in three or more attempts were chosen. Investigators calculated the predicted MEP and MIP values based on age, height, and weight
Measured: 3 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start30 Nov 2021
- Primary completion15 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
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 Inhalation InjuryStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- The exercise group received inspiratory muscle training in addition to routine chest physiotherapy (group A). The Control group received only routine chest physiotherapy (group B).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Takey Ahmed, Cairo University
- Investigators
- Maha A El monem, Ass Prof, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190497
- Sponsor's protocol ID
- IMT in inhalation injury
- Status last verified
- Dec 2021
- First submitted
- 11 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At first study protocol and informed consent
Publications
Gupta K, Mehrotra M, Kumar P, Gogia AR, Prasad A, Fisher JA. Smoke Inhalation Injury: Etiopathogenesis, Diagnosis, and Management. Indian J Crit Care Med. 2018 Mar;22(3):180-188. doi: 10.4103/ijccm.IJCCM_460_17.
PubMed 29657376
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training on Clinical Predictors of Respiratory Muscle Strength and Lung Function in Burned Patients With Inhalation Injury
- ClinicalTrials.gov ID
- NCT05190497
- Acronym / sponsor ID
- IMT in inhalation injury
- Keywords
- INSPIRATORT TRAINING -INHALATION INJURY
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 15 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 13 Jan 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.
The current study aimed to investigate the effect of inspiratory muscle training (IMT) on pulmonary functions (FEV1and FVC), and respiratory muscle strength in patients with inhalation injury, which may prove to be a promising intervention helping to improve exercise tolerance, relieve dyspnea and suggests an improvement in respiratory muscle function.
Detailed description
Forty male patients suffering from inhalation injury were been included in this study, Participants' ages ranged from 20-35 years old. Patients were selected from the burn department, Om El-Masreen hospital, and randomly assigned into two equal groups.
The exercise group received inspiratory muscle training in addition to routine chest physiotherapy in the form of (deep breathing, coughing, and early ambulation) three times per week for four weeks (group A). The Control group received only routine chest physiotherapy (group B). This study obtained ethical approval by the institutional review board of the Faculty of Physical Therapy - Cairo University, with reference number: P.T.REC/012/003431
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The exercise group received inspiratory muscle training in addition to routine chest physiotherapy (group A). The Control group received only routine chest physiotherapy (group B).
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Device: Exercise groupinspiratory muscle training in addition to routine chest physiotherapy in the form of (deep breathing, coughing, and early ambulation) |
| control | No intervention | –The Control group received only routine chest physiotherapy |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male patients suffering from inhalation injury.
- Participant age ranged from 20-35 years old.
- All patients had the same medical care.
- Participants have received a good explanation of the treatment and measurement device.
- Treatment was conducted one month after inhalation injury.
Key exclusion criteria (4 listed)
- Patients were excluded from this study for any of the following cases such as
- Instability of patient's medical condition.
- Presence of any diseases that could affect the study results.
- Participants having respiratory, cardiac, or neurological diseases that affect pulmonary functions.
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 |
|---|---|---|
| Exercise groupAlso: INSPIRATORY MUSCLE TRAININGMaximal respiratory pressure and reflecting muscles strength were measured by a mouth pressure meter | Device | intervention group |
Primary outcome
PULMONARY FUNCTION TEST
Time frame: 3 MONTHS
Each patient's weight in kilograms, and height in meters were recorded and entered the machine. An individual sat in a chair and inhaled deeply before closing their mouth tightly around the tube. Several exercises were carried out until the patient comprehended and was comfortable with the instruction. The patient inhaled deeply and exhaled as quickly as possible into the spirometer(Morgan Trans Flow Test Vicatest p2 (Kent, ME 87 ED, England).
Respiratory muscles Strength Measurement
Time frame: 3 MONTHS
Maximal respiratory pressure and reflecting muscles strength were measured by a mouth pressure meter (Pony FX; COSMED, Rome, Italy) in the sitting position. The highest maximal expiratory pressure (MEP) in cmH2O, and maximal inspiratory pressure (MIP) in cmH2O values in three or more attempts were chosen. Investigators calculated the predicted MEP and MIP values based on age, height, and weight
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Background: PubMed 29657376Gupta K, Mehrotra M, Kumar P, Gogia AR, Prasad A, Fisher JA. Smoke Inhalation Injury: Etiopathogenesis, Diagnosis, and Management. Indian J Crit Care Med. 2018 Mar;22(3):180-188. doi: 10.4103/ijccm.IJCCM_460_17.
- Individual participant dataSharing planned: Yes. At first study protocol and informed consent
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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.
Maha A El monem, Ass Prof study chair
Cairo 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 Exercise group in people with Inhalation Injury and Pulmonary Function, run by Cairo University at 1 site in Egypt.
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 4 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: status not confirmed, as of the sponsor's last update on 13 Jan 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KHALED T AHMED, Asso Prof (00201115586016, khaled.takey@must.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PULMONARY FUNCTION TEST (time frame: 3 MONTHS). The study lists 2 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 NCT05190497, 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 13 Jan 2022.