Mechanical Ventilation ComplicationMHINCT06349785
Manual Hyperinflation and Physical Therapy Program on Lung Recruitment Mechanically Ventilated Pediatric Patients
A study testing rehabilitation of mechanically ventilated patients and supportive care in people with Mechanical Ventilation Complication and Physical Disability, run by New Ismailia National University at 1 site in Egypt.
Trial summary
The purpose of this study is to investigate the immediate combined effects of Manual Hyperinflation and standard Physical therapy program on lung recruitment and secretion mass in mechanically ventilated pediatric patients aged between 10-15 years 'old Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Mechanical Ventilation Complication, Physical Disability
- What is being tested?
- rehabilitation of mechanically ventilated patients and supportive care
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2023to 29 Mar 2024
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The patients will be aged 10-15 years,
- receiving mechanical ventilation via an endotracheal tube for at least 24 h
- presenting with vital signs in the normal range.
- All patients are suffering from lower respiratory tract infection like pneumonia, bronchitis and acute exacerbation of bronchiectasis
Who cannot join
- Patients with history of thoracic surgery
- Patients with pneumothorax or acute respiratory distress syndrome
- Patients with severe acute head injury
- Patients use inotropes and vasopressors drugs
- Patients with severe Broncho pleural fistula, rib fracture, emphysema bullae, lung abscess, patients with history of preterm birth or heart disease.
- Patients who requiring mechanical ventilation with a peak inspiratory pressure (PIP)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Combined Manual Hyperinflation and Standard Physical Therapy Program on Lung Recruitment in Mechanically Ventilated Pediatric Patients: A Randomized Clinical Trial
The purpose of this study is to investigate the immediate combined effects of Manual Hyperinflation and standard Physical therapy program on lung recruitment and secretion mass in mechanically ventilated pediatric patients aged between 10-15 years 'old
Read the detailed description
In developing countries, lower respiratory tract infection is a major cause of death in children, with severely ill patients being admitted to the critical-care unit. While physical therapists commonly use the manual hyperinflation (MHI) technique for secretion mass clearance in critical-care patients, its efficacy has not been determined in pediatric patients.
Manual hyperinflation is a frequently maneuver used in critically ill intubated and mechanically ventilated patients. With MHI, patients are disconnected from the mechanical ventilator after which their lungs are temporarily ventilated with a manual ventilation bag. so, by applying a larger than normal volume at a low inspiratory pause and expiration with a high expiratory flow, MHI is suggested to mimic a normal cough.
Propagation of airway secretions from the smaller toward the larger airways, then allows for easy removed of airway secretions with the airway suction. finally, MHI could prevent airway plugging and even promote alveolar recruitment. so the aim of the study is to enhance lung recruitment using MHI combined with standard Physical therapy program
- Being tested
- rehabilitation of mechanically ventilated patients, supportive care
- Keywords
- MHI, Physical Therapy, Mechanically ventilated patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitation of mechanically ventilated patientsDevice
Also called rehabilitation by using combined physical therapy and manual hyperinflation
- mechanical ventilation
- silicon resuscitation bag (500ml) connected to pressure manometer with an oxygen flow of 10 l.min-1
- Endotracheal closed suction with pressure control ventilation (PCV)
supportive careProcedure or surgery
Also called physical therapy for pediatric respiratory disorders
- Children in study group B will receive standard Physical therapy program including suction, percussion and vibration with total duration of session in group a will be 15 minutes, daily for successive two weeks
| Study group | Role | What they receive |
|---|---|---|
| study group A | Experimental | Assigned Children in the study will receive manual hyperinflation and standard physical therapy program. Manual hyperinflation (MHI): Manual hyperinflation will be performed by single physical therapist using a silicone resuscitator bag . The resuscitator bag (maximum volume of 500 mL) was connected to a pressure manometer with an oxygen flow of 10 L. min-1 with the total duration of session in group A will be 15 minutes, daily for 2 weeks Receives: Device: rehabilitation of mechanically ventilated patients; Procedure: supportive care |
| study group B | Active comparator | - Children in study group B will receive standard Physical therapy program including suction, percussion and vibration with total duration of session in group a will be 15 minutes, daily for 2 weeks Receives: Procedure: supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
change the respiratory functions
By increasing tidal volume
Measured: 2 weeks
change the respiratory mechanics
increasing inspiratory capacity
Measured: 2 weeks
change the bronchospasm
modifying mean airway pressure
Measured: 2 weeks
change the amount of ventilation
increasing the oxygen saturation
Measured: 2 weeks
Secondary outcomes (2)
decreasing the amount of secretions
by monitoring the change of amount of secretions collection calibrated tube attached to a closed suction system to calculate the secretion mass before and after treatment using: Suction by Endotracheal closed suction with pressure control ventilation (PCV) will be performed. The duration of suction was 10 s with 5-s rest for each set. Three sets of suction with a closed suction system will be used for both groups of patients.
Measured: 2 weeks
weaning from mechanical ventilator
by improving previously mentioned respiratory function
Measured: from 2 to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start20 Dec 2023
- Primary completion1 Mar 2024
- Study completion29 Mar 2024
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 Mechanical Ventilation ComplicationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Ismailia National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdel Moeim Abo EL Ros, New Ismailia National University
- Investigators
- Amr K Abo Takia, MD, Study director, college of medicine Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349785
- Sponsor's protocol ID
- P.T.REC/012/003858
- Acronym
- MHI
- Status last verified
- Apr 2024
- First submitted
- 23 Mar 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will not be available to other researchers
Publications
Ubeda Tikkanen A, Nathan M, Sleeper LA, Flavin M, Lewis A, Nimec D, Mayer JE, Del Nido P. Predictors of Postoperative Rehabilitation Therapy Following Congenital Heart Surgery. J Am Heart Assoc. 2018 May 12;7(10):e008094. doi: 10.1161/JAHA.117.008094.
PubMed 29754124
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Manual Hyperinflation and Standard Physical Therapy Program on Lung Recruitment in Mechanically Ventilated Pediatric Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06349785
- Acronym / sponsor ID
- MHI / P.T.REC/012/003858
- Keywords
- MHI, Physical Therapy, Mechanically ventilated patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- New Ismailia National UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 5 Apr 2024 (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 this study is to investigate the immediate combined effects of Manual Hyperinflation and standard Physical therapy program on lung recruitment and secretion mass in mechanically ventilated pediatric patients aged between 10-15 years 'old
Detailed description
In developing countries, lower respiratory tract infection is a major cause of death in children, with severely ill patients being admitted to the critical-care unit. While physical therapists commonly use the manual hyperinflation (MHI) technique for secretion mass clearance in critical-care patients, its efficacy has not been determined in pediatric patients.
Manual hyperinflation is a frequently maneuver used in critically ill intubated and mechanically ventilated patients. With MHI, patients are disconnected from the mechanical ventilator after which their lungs are temporarily ventilated with a manual ventilation bag. so, by applying a larger than normal volume at a low inspiratory pause and expiration with a high expiratory flow, MHI is suggested to mimic a normal cough.
Propagation of airway secretions from the smaller toward the larger airways, then allows for easy removed of airway secretions with the airway suction. finally, MHI could prevent airway plugging and even promote alveolar recruitment. so the aim of the study is to enhance lung recruitment using MHI combined with standard Physical therapy program
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| study group A | Experimental | Device: rehabilitation of mechanically ventilated patients, Procedure: supportive careAssigned Children in the study will receive manual hyperinflation and standard physical therapy program. Manual hyperinflation (MHI): Manual hyperinflation will be performed by single physical therapist using a silicone resuscitator bag . The resuscitator bag (maximum volume of 500 mL) was connected to a pressure manometer with an oxygen flow of 10 L. min-1 with the total duration of session in group A will be 15 minutes, daily for 2 weeks |
| study group B | Active comparator | Procedure: supportive care- Children in study group B will receive standard Physical therapy program including suction, percussion and vibration with total duration of session in group a will be 15 minutes, daily for 2 weeks |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The patients will be aged 10-15 years,
- receiving mechanical ventilation via an endotracheal tube for at least 24 h
- presenting with vital signs in the normal range.
- All patients are suffering from lower respiratory tract infection like pneumonia, bronchitis and acute exacerbation of bronchiectasis
Key exclusion criteria (6 listed)
- Patients with history of thoracic surgery
- Patients with pneumothorax or acute respiratory distress syndrome
- Patients with severe acute head injury
- Patients use inotropes and vasopressors drugs
- Patients with severe Broncho pleural fistula, rib fracture, emphysema bullae, lung abscess, patients with history of preterm birth or heart disease.
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 |
|---|---|---|
| rehabilitation of mechanically ventilated patientsAlso: rehabilitation by using combined physical therapy and manual hyperinflation1. mechanical ventilation 2. silicon resuscitation bag (500ml) connected to pressure manometer with an oxygen flow of 10 l.min-1 3. Endotracheal closed suction with pressure control ventilation (PCV) | Device | study group A |
| supportive careAlso: physical therapy for pediatric respiratory disorders- Children in study group B will receive standard Physical therapy program including suction, percussion and vibration with total duration of session in group a will be 15 minutes, daily for successive two weeks | Procedure or surgery | study group A, study group B |
Primary outcome
change the respiratory functions
Time frame: 2 weeks
By increasing tidal volume
change the respiratory mechanics
Time frame: 2 weeks
increasing inspiratory capacity
change the bronchospasm
Time frame: 2 weeks
modifying mean airway pressure
change the amount of ventilation
Time frame: 2 weeks
increasing the oxygen saturation
2 secondary outcomes
decreasing the amount of secretions
Time frame: 2 weeks
weaning from mechanical ventilator
Time frame: from 2 to 4 weeks
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 Apr 2024.
- Background: PubMed 29754124Ubeda Tikkanen A, Nathan M, Sleeper LA, Flavin M, Lewis A, Nimec D, Mayer JE, Del Nido P. Predictors of Postoperative Rehabilitation Therapy Following Congenital Heart Surgery. J Am Heart Assoc. 2018 May 12;7(10):e008094. doi: 10.1161/JAHA.117.008094.
- open access article from national library of medicineLink provided by the sponsor.
- Individual participant dataSharing planned: No. data will not be available to other researchers
Related trials for Mechanical Ventilation Complication
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The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Recruiting
Humidification Effects on Airway Complications and Clinical Outcomes in Trauma ICU Patients on Mechanical Ventilation
Respiratory Insufficiency, Wounds and Injuries
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Recruiting
Platform of Randomized Adaptive Clinical Trials in Critical Illness
Respiratory Insufficiency, Extracorporeal Membrane Oxygenation Complication
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.
Amr K Abo Takia, MD study director
college of medicine Suez Canal 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 rehabilitation of mechanically ventilated patients and supportive care in people with Mechanical Ventilation Complication and Physical Disability, run by New Ismailia National 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 4 inclusion and 6 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 Apr 2024. 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?
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?
change the respiratory functions (time frame: 2 weeks). 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 NCT06349785, 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 5 Apr 2024.