Pneumonia ChildhoodNCT06154876
Effect Of Cough Assist Device On Hemodynamic Status And Oxygen Saturation For Ventilated Children
A study testing Cough assist device in people with Pneumonia Childhood and Intensive Care Unit, run by Cairo University at 1 site in Egypt.
Trial summary
Statement of the problem: •Is there an effect of the cough assist device on Hemodynamic status and oxygen saturation for ventilated children? Null hypothesis There will be no effect of cough assist device on hemodynamic status and oxygen saturation for ventilated children. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Pneumonia Childhood, Intensive Care Unit, Children
- What is being tested?
- Cough assist device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 15 Oct 2023
- 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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of both sexes, with age ranged from 4-9 years old.
- Children will diagnosed with pneumonia.
- Children will intubated on mechanical ventilation.
- All children should be vitally stable during the study period.
Who cannot join
- Hemodynamically unstable child.
- Child with diaphragmatic hernia.
- Child with pneumothorax (if chest tube is present).
- Child with raised intracranial pressure.
- Child with recent upper Gastrointestinal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Statement of the problem:
•Is there an effect of the cough assist device on Hemodynamic status and oxygen saturation for ventilated children? Null hypothesis There will be no effect of cough assist device on hemodynamic status and oxygen saturation for ventilated children.
Read the detailed description
Subjects:
The study targets the children from both sexes.diagnosed with pneumonia in intensive care unit. Sample size estimation will be carried out to determine the recruited number of children, selected randomly from Cairo University pediatric specialized hospital, Cairo to participate in the study.
Study design:
Randomized controlled clinical trial. Children will receive intervention type randomly,25 child will receive traditional chest physical therapy (postural drainage, percussion and vibration, end expiratory pressure) and bed mobility exercise.and the other 25 child will receive cough assist device in addition to traditional chest physical therapy (postural drainage, percussion and vibration, end expiratory pressure) and bed mobility exercise.
Children will be assessed by measuring heart rate, respiratory rate, blood pressure which reflect the physiological status, oxygen saturation,expired Tidal Volume and dynamic lung compliance which reflect clinical improvement of chest condition before and after receiving intervention
- Conditions
- Pneumonia Childhood, Intensive Care Unit, Children
- Being tested
- Cough assist device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cough assist deviceDevice
Also called Designed chest physical therapy
Cough assist device Cough Assist clears secretions from the lungs by gradually applying positive air pressure to the airway and then rapidly shifting to negative air pressure . The resulting high expiratory flow simulates a deep, natural cough.
Designed chest physical therapy Percussion, vibration, end expiratory pressure and bed mobility exercise.
| Study group | Role | What they receive |
|---|---|---|
| Cough assist device and designed chest physical therapy | Experimental | Cough assist device involved 3-5 cycles with insufflation/exsufflation pressure beginning with +15 cm H2O to -15 cm H2O and maximum pressure of +40 cm H2O to -40 cm H2O for 4-5 sets for pediatric patients .and percussion, vibration, end expiratory pressure and bed mobility exercise. Receives: Device: Cough assist device |
| Designed chest physical therapy | Active comparator | Percussion, vibration, end expiratory pressure and bed mobility exercise. Receives: Device: Cough assist device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of oxygen saturation
Pulse oximeter attached to the child and recorded oxygen saturation before and after intervention.
Measured: 14 days for each participant or time of weaning
Assessment of expired Tidal Volume
Expired Tidal volume recorded from mechanical ventilation attached to the child before and after intervention
Measured: 14 days for each participant or time of weaning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start1 Dec 2021
- Primary completion30 Sep 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia ChildhoodStudies 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
- Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nour Reda Abdelmonem Hafez, Cairo University
- Investigators
- Nour Reda, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154876
- Sponsor's protocol ID
- P.T.REC./012/003526
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Cough Assist Device On Hemodynamic Status And Oxygen Saturation For Ventilated Children
- ClinicalTrials.gov ID
- NCT06154876
- Acronym / sponsor ID
- P.T.REC./012/003526
- Conditions
- Pneumonia Childhood, Intensive Care Unit, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 4 Dec 2023 (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.
Statement of the problem:
•Is there an effect of the cough assist device on Hemodynamic status and oxygen saturation for ventilated children? Null hypothesis There will be no effect of cough assist device on hemodynamic status and oxygen saturation for ventilated children.
Detailed description
Subjects:
The study targets the children from both sexes.diagnosed with pneumonia in intensive care unit. Sample size estimation will be carried out to determine the recruited number of children, selected randomly from Cairo University pediatric specialized hospital, Cairo to participate in the study.
Study design:
Randomized controlled clinical trial. Children will receive intervention type randomly,25 child will receive traditional chest physical therapy (postural drainage, percussion and vibration, end expiratory pressure) and bed mobility exercise.and the other 25 child will receive cough assist device in addition to traditional chest physical therapy (postural drainage, percussion and vibration, end expiratory pressure) and bed mobility exercise.
Children will be assessed by measuring heart rate, respiratory rate, blood pressure which reflect the physiological status, oxygen saturation,expired Tidal Volume and dynamic lung compliance which reflect clinical improvement of chest condition before and after receiving intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Cough assist device and designed chest physical therapy | Experimental | Device: Cough assist deviceCough assist device involved 3-5 cycles with insufflation/exsufflation pressure beginning with +15 cm H2O to -15 cm H2O and maximum pressure of +40 cm H2O to -40 cm H2O for 4-5 sets for pediatric patients .and percussion, vibration, end expiratory pressure and bed mobility exercise. |
| Designed chest physical therapy | Active comparator | Device: Cough assist devicePercussion, vibration, end expiratory pressure and bed mobility exercise. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children of both sexes, with age ranged from 4-9 years old.
- Children will diagnosed with pneumonia.
- Children will intubated on mechanical ventilation.
- All children should be vitally stable during the study period.
Key exclusion criteria (5 listed)
- Hemodynamically unstable child.
- Child with diaphragmatic hernia.
- Child with pneumothorax (if chest tube is present).
- Child with raised intracranial pressure.
- Child with recent upper Gastrointestinal surgery
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 |
|---|---|---|
| Cough assist deviceAlso: Designed chest physical therapyCough assist device Cough Assist clears secretions from the lungs by gradually applying positive air pressure to the airway and then rapidly shifting to negative air pressure . The resulting high expiratory flow simulates a deep, natural cough. Designed chest physical therapy Percussion, vibration, end expiratory pressure and bed mobility exercise. | Device | Cough assist device and designed chest physical therapy, Designed chest physical therapy |
Primary outcome
Assessment of oxygen saturation
Time frame: 14 days for each participant or time of weaning
Pulse oximeter attached to the child and recorded oxygen saturation before and after intervention.
Assessment of expired Tidal Volume
Time frame: 14 days for each participant or time of weaning
Expired Tidal volume recorded from mechanical ventilation attached to the child before and after intervention
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 4 Dec 2023.
Related trials for Pneumonia Childhood
RecruitingPhase 4
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease
Recruiting
Novel Tools to Improve Management of Paediatric Community-Acquired Pneumonia - ToolCAP
Pneumonia, Pneumonia Childhood
Recruiting
Optimising Antibiotic Use for Paediatric Lower Respiratory Tract Infections in Africa
Lower Respiratory Tract Infection (LRTI), Pneumonia
Not yet recruitingEarly Phase 1
3 vs. 5 Days of Amoxicillin for Childhood Pneumonia: An RCT
Community Acquired Pneumonia, Childhood Pneumonia
RecruitingPhase 4
Trial of an AI-enabled Digital Stethoscope to Improve Antibiotic Stewardship
Respiratory Infections in Children
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.
Nour Reda principal investigator
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 Cough assist device in people with Pneumonia Childhood and Intensive Care Unit, 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 4 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 4 Dec 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 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?
Assessment of oxygen saturation (time frame: 14 days for each participant or time of weaning). 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?
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 4 Dec 2023.