Ventilation Therapy; ComplicationsNCT04733261
Diaphragmatic Mobility In Ventilated Assisted Patients
A study testing Diaphragmatic mobility and Chest Physiotherapy in people with Ventilation Therapy; Complications, run by Aqua Medical Services (Pvt) Ltd at 1 site in Pakistan.
Trial summary
The study was a randomized controlled trial. A total of 24 patients who met the inclusion criteria were included in this study and randomly divided by sealed envelope method into Experimental and Control groups with 12 patients each. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventilation Therapy; Complications
- What is being tested?
- Diaphragmatic mobility and Chest Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2020to 28 Feb 2021
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 30 to 60
- Oro-tracheal or nasotracheal intubate; ventilator mode:- Synchronized intermittent mechanical ventilation(SIMV) or Pressure support SIMV
- Both Gender included have been aeration used for Acute Respiratory Failure( type 2) during SIMV/PSV used for at any rate 72 hours consecutively
- Hemodynamically secure with no vasopressin or else inotropes (apart from a dobutamine and dopamine infusion lesser than 5 gamma/Kg/min and a 3 gamma /Kg/min, correspondingly
- Positive end-expiratory pressure 5 to 7cm H2O
Who cannot join
- Neurological or neuromuscular disorders
- Dysfunction of Phrenic Nerve
- Insertion of a nasogastric tube (for example recent upper gastrointestinal surgery, oesophagal varies).
- Pulmonary embolism, Malignancy, Pneumothorax, trauma, fever
- Acutearrhythmias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness Of Diaphragmatic Mobility In Ventilated Assisted Patients
The study was a randomized controlled trial. A total of 24 patients who met the inclusion criteria were included in this study and randomly divided by sealed envelope method into Experimental and Control groups with 12 patients each. Assessment of arterial blood gas analyzer (oxygen saturation(SP02), heart rate (HR), respiratory rate(RR), the partial pressure of carbon dioxide(PCO2), the partial pressure of oxygen(PO2), Bicarbonate(HCO3), and potential of hydrogen(PH) and modes of the ventilator (SIMV and PSV) for both groups were carried out at baseline and after 4thsession.The control group was given Chest physiotherapy only. While the Experimental group received Chest physiotherapy with Diaphragmatic Mobility. Total 4 sessions were given on alternate days to both groups.
Read the detailed description
Most common state in the intensive care unit is an intensive care unit acquired weakness in seriously unwell patients who are artificially ventilated for an extended period of time. The most important aspect of mechanical ventilation in the disuse atrophy and deconditioning of a patient's inspiratory muscle since it can replace the patient's own respiratory muscle exertion. The diaphragm particularly counters to persistent mechanical ventilation with atrophy. Most sufferers who are admitted to an intensive care unit need artificial aeration. Due to weaknesses of respiratory muscle might augment the interval of mechanical ventilation and delay the phase of withdrawal of mechanical ventilation. The term weaning is used for the course of withdrawal of artificial aeration to facilitate the patient's own respiratory muscle effort in the intensive care unit. Ventilation is universal work, linking the entire body, the emotions, the nervous system and organs. The diaphragm is the primary breathing muscle that influencing with its contraction the inspiratory actions. Diaphragmatic breathing is recognized as normal breathing which involves corresponding movement of abdomen, upper and lower ribcage. Furthermore, functionality and sufficient use of the diaphragm muscle requires usual breathing. Thoracic breathing is recognized as unusual breathing that involves aeration from the upper chest, evidence by bigger upper rib cage movement, compare to lower rib cage movement. Weakness possibly will owe an extreme weight on the respiratory muscle, which might affect starting augmented airway conflict and also over-come lung compliance. Two most important factors that are broadly known as a reason of malfunction to with-drawl from mechanical ventilation are weakness or fatigue of diaphragm and accessory muscle of respiration. A dome-shaped muscular membrane that separates the abdomen from thoracic is a diaphragm. Nine hundred centimetre per square area is covert in adults. It is the most important and primary inspiratory muscle and it is able to condense itself to forty per cent as of residual to vital capacity. In fact, a one-sided paralysis of the phrenic nerve generates merely respiratory dysfunction because the stomach has the widespread capacity to functional preserved. The weakness of diaphragm muscle tends to be more worse in patients who are mechanically ventilated for a prolonged period of time with controlled modes of mechanical ventilator compared to spontaneous modes and also appear to be interrelated to patients voluntary inspiratory exertion even as ventilator-dependent. During inspiration, throughout the application of resistance in inspiratory muscles that may help in strengthening of inspiratory muscle and this technique is known as inspiratory muscle training. Patients who have difficulty in breathing and mechanically ventilated for more than 24 hours possibly will adversely affect diaphragmatic structure and function. Major factors such as reduced quality of life, increase the length of stay in the intensive care unit, increase death rate and reduced functional grades are due to extended artificial aeration. Moreover, extended artificial aeration is cheap, unbearable a big portion of hospital assets and a healthcare load that might keep on subsequent hospital ejection. An intervention invented to directly stretch the muscle fibre of diaphragm is known as the manual diaphragm release technique. Even though this intervention is widely used in some regions, there is no quantitative research or systematic trails or evaluating the result of this technique. The previous research conducted to find out the outcome of manual diaphragm release technique in chronic obstructive pulmonary disease. The objective of the study was to determine the effects of diaphragmatic mobility on improving ventilation in ventilated assisted patients, to determine the effects of diaphragmatic mobility in weaning off from mechanical ventilation in ventilated assisted patients, and to determine the additional effects of diaphragmatic mobility on respiration along with Chest Physical Therapy.
- Conditions
- Ventilation Therapy; Complications
- Being tested
- Diaphragmatic mobility, Chest Physiotherapy
- Keywords
- Respiration, Artificial, Diaphragm, Physical Therapy Modalities, Ventilators, Mechanical, Intensive Care Units
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic mobilityOther
Therapist will manually make contact with Pisiform Hypothenar region and last three fingers among the underneath the costal cartilage of the 7th in the direction of 10 ribs. For the duration of participant's inhalation, the counselor drag softly within a upward course accompany the increase motion of the ribs. For the period of expiration, the counselor will deepens make contact with in the direction of the internal costal border. Taking place consequent breathing, the counselor wanted on the way to expand traction as well as slickly make deeper the contact.
Chest PhysiotherapyOther
Patients allocated to the control group and interventional group received pulmonary rehabilitation two times a day beginning happening the day of entrance on the way to the intensive care unit. It consists of side-lying positioning with the head of the bed horizontal for at least 20 min with the most affected lung on chest x-ray positioned uppermost is also known as postural drainage, 4 sets of 6 cycles of expiratory chest wall vibrations , and airway suctioning at least three times through the endotracheal and tracheotomy tube disperse in the course of the management
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic mobility | Active comparator | The patient will be in supine, supported on one/two pillows under her head, and a bolster under her knees. Receives: Other: Diaphragmatic mobility |
| Chest Physiotherapy | Experimental | Give passive ROM exercise to all joints of the upper and lower extremities. Receives: Other: Chest Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Synchronized Intermittent- Mandatory Ventilation (SIMV)
Synchronized intermittent mandatory ventilation is a ventilator mode that enables partial mechanical assistance. This ventilator mode will provide a set number of breaths at a fixed tidal volume, but a patient can trigger a spontaneous breath with the volume determined by patient effort
Measured: 0 day
Pressure Support Ventilation (PSV)
For the spontaneously breathing patient, pressure support ventilation (PSV) has been advocated to limit barotrauma and to decrease the work of breathing. ... Airway pressure support is maintained until the patient's inspiratory flow falls below a certain cutoff (eg, 25% of peak flow).
Measured: 0 day
Synchronized Intermittent- Mandatory Ventilation (SIMV)
Synchronized intermittent mandatory ventilation is a ventilator mode that enables partial mechanical assistance. This ventilator mode will provide a set number of breaths at a fixed tidal volume, but a patient can trigger a spontaneous breath with the volume determined by patient effort
Measured: 4th day
Pressure Support Ventilation (PSV)
For the spontaneously breathing patient, pressure support ventilation (PSV) has been advocated to limit barotrauma and to decrease the work of breathing. ... Airway pressure support is maintained until the patient's inspiratory flow falls below a certain cutoff (eg, 25% of peak flow).
Measured: 4th day
Secondary outcomes (3)
Arterial Blood Gas ( ABGs) Test
An arterial-blood gas test measures the amounts of arterial gases, such as oxygen and carbon dioxide. An ABG test requires that a small volume of blood be drawn from the radial artery with a syringe and a thin needle, but sometimes the femoral artery in the groin or another site is used.
Measured: 0 day,4th day
Peripheral Capillary Oxygen Saturation (SPO2)
SpO2 stands for peripheral capillary oxygen saturation, an estimate of the amount of oxygen in the blood. More specifically, it is the percentage of oxygenated haemoglobin (haemoglobin containing oxygen) compared to the total amount of haemoglobin in the blood ( oxygenated and non-oxygenated haemoglobin).
Measured: 0 day,4th day
Chest X-ray
The chest x-ray is the most commonly performed diagnostic x-ray examination. A chest x-ray produces images of the heart, lungs, airways, blood vessels and the bones of the spine and chest.
Measured: 0 day,4th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start15 Mar 2020
- Primary completion15 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ventilation Therapy; ComplicationsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aqua Medical Services (Pvt) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Mir Arif Hussain, Aqua Medical Services (Pvt) Ltd
- Investigators
- Dr Abdul Ghafoor Sajjad,, PHD*, Principal investigator, Shifa Tameer e milat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733261
- Sponsor's protocol ID
- Rimsha zeb 00568
- Status last verified
- Sep 2021
- First submitted
- 22 Dec 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jounieaux V, Duran A, Levi-Valensi P. Synchronized intermittent mandatory ventilation with and without pressure support ventilation in weaning patients with COPD from mechanical ventilation. Chest. 1994 Apr;105(4):1204-10. doi: 10.1378/chest.105.4.1204.
PubMed 8162750Hodgson CL, Tipping CJ. Physiotherapy management of intensive care unit-acquired weakness. J Physiother. 2017 Jan;63(1):4-10. doi: 10.1016/j.jphys.2016.10.011. Epub 2016 Nov 26.
PubMed 27989729Bordoni B, Marelli F, Morabito B, Sacconi B. Manual evaluation of the diaphragm muscle. Int J Chron Obstruct Pulmon Dis. 2016 Aug 18;11:1949-56. doi: 10.2147/COPD.S111634. eCollection 2016.
PubMed 27574419Moodie L, Reeve J, Elkins M. Inspiratory muscle training increases inspiratory muscle strength in patients weaning from mechanical ventilation: a systematic review. J Physiother. 2011;57(4):213-21. doi: 10.1016/S1836-9553(11)70051-0.
PubMed 22093119Bissett B, Leditschke IA, Green M, Marzano V, Collins S, Van Haren F. Inspiratory muscle training for intensive care patients: A multidisciplinary practical guide for clinicians. Aust Crit Care. 2019 May;32(3):249-255. doi: 10.1016/j.aucc.2018.06.001. Epub 2018 Jul 11.
PubMed 30007823Rocha T, Souza H, Brandao DC, Rattes C, Ribeiro L, Campos SL, Aliverti A, de Andrade AD. The Manual Diaphragm Release Technique improves diaphragmatic mobility, inspiratory capacity and exercise capacity in people with chronic obstructive pulmonary disease: a randomised trial. J Physiother. 2015 Oct;61(4):182-9. doi: 10.1016/j.jphys.2015.08.009. Epub 2015 Sep 19.
PubMed 26386894Nair A, Alaparthi GK, Krishnan S, Rai S, Anand R, Acharya V, Acharya P. Comparison of Diaphragmatic Stretch Technique and Manual Diaphragm Release Technique on Diaphragmatic Excursion in Chronic Obstructive Pulmonary Disease: A Randomized Crossover Trial. Pulm Med. 2019 Jan 3;2019:6364376. doi: 10.1155/2019/6364376. eCollection 2019.
PubMed 30719351Yang PH, Wang CS, Wang YC, Yang CJ, Hung JY, Hwang JJ, Wang TH, Chuang IC, Huang MS. Outcome of physical therapy intervention on ventilator weaning and functional status. Kaohsiung J Med Sci. 2010 Jul;26(7):366-72. doi: 10.1016/S1607-551X(10)70060-7.
PubMed 20638039
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Diaphragmatic Mobility In Ventilated Assisted Patients
- ClinicalTrials.gov ID
- NCT04733261
- Acronym / sponsor ID
- Rimsha zeb 00568
- Conditions
- Ventilation Therapy; Complications
- Keywords
- Respiration, Artificial, Diaphragm, Physical Therapy Modalities, Ventilators, Mechanical, Intensive Care Units
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aqua Medical Services (Pvt) LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 2 Feb 2021 (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 study was a randomized controlled trial. A total of 24 patients who met the inclusion criteria were included in this study and randomly divided by sealed envelope method into Experimental and Control groups with 12 patients each. Assessment of arterial blood gas analyzer (oxygen saturation(SP02), heart rate (HR), respiratory rate(RR), the partial pressure of carbon dioxide(PCO2), the partial pressure of oxygen(PO2), Bicarbonate(HCO3), and potential of hydrogen(PH) and modes of the ventilator (SIMV and PSV) for both groups were carried out at baseline and after 4thsession.The control group was given Chest physiotherapy only. While the Experimental group received Chest physiotherapy with Diaphragmatic Mobility. Total 4 sessions were given on alternate days to both groups.
Detailed description
Most common state in the intensive care unit is an intensive care unit acquired weakness in seriously unwell patients who are artificially ventilated for an extended period of time. The most important aspect of mechanical ventilation in the disuse atrophy and deconditioning of a patient's inspiratory muscle since it can replace the patient's own respiratory muscle exertion. The diaphragm particularly counters to persistent mechanical ventilation with atrophy. Most sufferers who are admitted to an intensive care unit need artificial aeration. Due to weaknesses of respiratory muscle might augment the interval of mechanical ventilation and delay the phase of withdrawal of mechanical ventilation. The term weaning is used for the course of withdrawal of artificial aeration to facilitate the patient's own respiratory muscle effort in the intensive care unit. Ventilation is universal work, linking the entire body, the emotions, the nervous system and organs. The diaphragm is the primary breathing muscle that influencing with its contraction the inspiratory actions. Diaphragmatic breathing is recognized as normal breathing which involves corresponding movement of abdomen, upper and lower ribcage. Furthermore, functionality and sufficient use of the diaphragm muscle requires usual breathing. Thoracic breathing is recognized as unusual breathing that involves aeration from the upper chest, evidence by bigger upper rib cage movement, compare to lower rib cage movement. Weakness possibly will owe an extreme weight on the respiratory muscle, which might affect starting augmented airway conflict and also over-come lung compliance. Two most important factors that are broadly known as a reason of malfunction to with-drawl from mechanical ventilation are weakness or fatigue of diaphragm and accessory muscle of respiration. A dome-shaped muscular membrane that separates the abdomen from thoracic is a diaphragm. Nine hundred centimetre per square area is covert in adults. It is the most important and primary inspiratory muscle and it is able to condense itself to forty per cent as of residual to vital capacity. In fact, a one-sided paralysis of the phrenic nerve generates merely respiratory dysfunction because the stomach has the widespread capacity to functional preserved. The weakness of diaphragm muscle tends to be more worse in patients who are mechanically ventilated for a prolonged period of time with controlled modes of mechanical ventilator compared to spontaneous modes and also appear to be interrelated to patients voluntary inspiratory exertion even as ventilator-dependent. During inspiration, throughout the application of resistance in inspiratory muscles that may help in strengthening of inspiratory muscle and this technique is known as inspiratory muscle training. Patients who have difficulty in breathing and mechanically ventilated for more than 24 hours possibly will adversely affect diaphragmatic structure and function. Major factors such as reduced quality of life, increase the length of stay in the intensive care unit, increase death rate and reduced functional grades are due to extended artificial aeration. Moreover, extended artificial aeration is cheap, unbearable a big portion of hospital assets and a healthcare load that might keep on subsequent hospital ejection. An intervention invented to directly stretch the muscle fibre of diaphragm is known as the manual diaphragm release technique. Even though this intervention is widely used in some regions, there is no quantitative research or systematic trails or evaluating the result of this technique. The previous research conducted to find out the outcome of manual diaphragm release technique in chronic obstructive pulmonary disease. The objective of the study was to determine the effects of diaphragmatic mobility on improving ventilation in ventilated assisted patients, to determine the effects of diaphragmatic mobility in weaning off from mechanical ventilation in ventilated assisted patients, and to determine the additional effects of diaphragmatic mobility on respiration along with Chest Physical Therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic mobility | Active comparator | Other: Diaphragmatic mobilityThe patient will be in supine, supported on one/two pillows under her head, and a bolster under her knees. |
| Chest Physiotherapy | Experimental | Other: Chest PhysiotherapyGive passive ROM exercise to all joints of the upper and lower extremities. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 30 to 60
- Oro-tracheal or nasotracheal intubate; ventilator mode:- Synchronized intermittent mechanical ventilation(SIMV) or Pressure support SIMV
- Both Gender included have been aeration used for Acute Respiratory Failure( type 2) during SIMV/PSV used for at any rate 72 hours consecutively
- Hemodynamically secure with no vasopressin or else inotropes (apart from a dobutamine and dopamine infusion lesser than 5 gamma/Kg/min and a 3 gamma /Kg/min, correspondingly
- Positive end-expiratory pressure 5 to 7cm H2O
Key exclusion criteria (5 listed)
- Neurological or neuromuscular disorders
- Dysfunction of Phrenic Nerve
- Insertion of a nasogastric tube (for example recent upper gastrointestinal surgery, oesophagal varies).
- Pulmonary embolism, Malignancy, Pneumothorax, trauma, fever
- Acutearrhythmias
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 |
|---|---|---|
| Diaphragmatic mobilityTherapist will manually make contact with Pisiform Hypothenar region and last three fingers among the underneath the costal cartilage of the 7th in the direction of 10 ribs. For the duration of participant's inhalation, the counselor drag softly within a upward course accompany the increase motion of the ribs. For the period of expiration, the counselor will deepens make contact with in the direction of the internal costal border. Taking place consequent breathing, the counselor wanted on the way to expand traction as well as slickly make deeper the contact. | Other | Diaphragmatic mobility |
| Chest PhysiotherapyPatients allocated to the control group and interventional group received pulmonary rehabilitation two times a day beginning happening the day of entrance on the way to the intensive care unit. It consists of side-lying positioning with the head of the bed horizontal for at least 20 min with the most affected lung on chest x-ray positioned uppermost is also known as postural drainage, 4 sets of 6 cycles of expiratory chest wall vibrations , and airway suctioning at least three times through the endotracheal and tracheotomy tube disperse in the course of the management | Other | Chest Physiotherapy |
Primary outcome
Synchronized Intermittent- Mandatory Ventilation (SIMV)
Time frame: 0 day
Synchronized intermittent mandatory ventilation is a ventilator mode that enables partial mechanical assistance. This ventilator mode will provide a set number of breaths at a fixed tidal volume, but a patient can trigger a spontaneous breath with the volume determined by patient effort
Pressure Support Ventilation (PSV)
Time frame: 0 day
For the spontaneously breathing patient, pressure support ventilation (PSV) has been advocated to limit barotrauma and to decrease the work of breathing. ... Airway pressure support is maintained until the patient's inspiratory flow falls below a certain cutoff (eg, 25% of peak flow).
Synchronized Intermittent- Mandatory Ventilation (SIMV)
Time frame: 4th day
Synchronized intermittent mandatory ventilation is a ventilator mode that enables partial mechanical assistance. This ventilator mode will provide a set number of breaths at a fixed tidal volume, but a patient can trigger a spontaneous breath with the volume determined by patient effort
Pressure Support Ventilation (PSV)
Time frame: 4th day
For the spontaneously breathing patient, pressure support ventilation (PSV) has been advocated to limit barotrauma and to decrease the work of breathing. ... Airway pressure support is maintained until the patient's inspiratory flow falls below a certain cutoff (eg, 25% of peak flow).
3 secondary outcomes
Arterial Blood Gas ( ABGs) Test
Time frame: 0 day,4th day
Peripheral Capillary Oxygen Saturation (SPO2)
Time frame: 0 day,4th day
Chest X-ray
Time frame: 0 day,4th day
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 Sep 2021.
- Background: PubMed 8162750Jounieaux V, Duran A, Levi-Valensi P. Synchronized intermittent mandatory ventilation with and without pressure support ventilation in weaning patients with COPD from mechanical ventilation. Chest. 1994 Apr;105(4):1204-10. doi: 10.1378/chest.105.4.1204.
- Background: PubMed 27989729Hodgson CL, Tipping CJ. Physiotherapy management of intensive care unit-acquired weakness. J Physiother. 2017 Jan;63(1):4-10. doi: 10.1016/j.jphys.2016.10.011. Epub 2016 Nov 26.
- Background: PubMed 27574419Bordoni B, Marelli F, Morabito B, Sacconi B. Manual evaluation of the diaphragm muscle. Int J Chron Obstruct Pulmon Dis. 2016 Aug 18;11:1949-56. doi: 10.2147/COPD.S111634. eCollection 2016.
- Background: PubMed 22093119Moodie L, Reeve J, Elkins M. Inspiratory muscle training increases inspiratory muscle strength in patients weaning from mechanical ventilation: a systematic review. J Physiother. 2011;57(4):213-21. doi: 10.1016/S1836-9553(11)70051-0.
- Background: PubMed 30007823Bissett B, Leditschke IA, Green M, Marzano V, Collins S, Van Haren F. Inspiratory muscle training for intensive care patients: A multidisciplinary practical guide for clinicians. Aust Crit Care. 2019 May;32(3):249-255. doi: 10.1016/j.aucc.2018.06.001. Epub 2018 Jul 11.
- Background: PubMed 26386894Rocha T, Souza H, Brandao DC, Rattes C, Ribeiro L, Campos SL, Aliverti A, de Andrade AD. The Manual Diaphragm Release Technique improves diaphragmatic mobility, inspiratory capacity and exercise capacity in people with chronic obstructive pulmonary disease: a randomised trial. J Physiother. 2015 Oct;61(4):182-9. doi: 10.1016/j.jphys.2015.08.009. Epub 2015 Sep 19.
- Background: PubMed 30719351Nair A, Alaparthi GK, Krishnan S, Rai S, Anand R, Acharya V, Acharya P. Comparison of Diaphragmatic Stretch Technique and Manual Diaphragm Release Technique on Diaphragmatic Excursion in Chronic Obstructive Pulmonary Disease: A Randomized Crossover Trial. Pulm Med. 2019 Jan 3;2019:6364376. doi: 10.1155/2019/6364376. eCollection 2019.
- Background: PubMed 20638039Yang PH, Wang CS, Wang YC, Yang CJ, Hung JY, Hwang JJ, Wang TH, Chuang IC, Huang MS. Outcome of physical therapy intervention on ventilator weaning and functional status. Kaohsiung J Med Sci. 2010 Jul;26(7):366-72. doi: 10.1016/S1607-551X(10)70060-7.
- Individual participant dataSharing planned: No
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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.
Dr Abdul Ghafoor Sajjad,, PHD* principal investigator
Shifa Tameer e milat 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 Diaphragmatic mobility and Chest Physiotherapy in people with Ventilation Therapy; Complications, run by Aqua Medical Services (Pvt) Ltd 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 5 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 Sep 2021. 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?
Synchronized Intermittent- Mandatory Ventilation (SIMV) (time frame: 0 day). The study lists 4 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 NCT04733261, which also lists 8 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 Sep 2021.