Mechanical VentilationNCT00702169
Continuous Monitoring of the Lungs Ventilation Dynamics During Mechanical Ventilation
An observational study of Mechanical Ventilation, run by Carmel Medical Center at 1 site in Israel.
Trial summary
Background: Patients that suffer from respiratory failure and need mechanical ventilation are at risk of further deterioration due to complications induced by progression of lung disease or the mechanical ventilation. Read more about this study
- Who is it for?
- Ages 1 day to 3 months
- Conditions the study is for
- Mechanical Ventilation
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2007to Mar 2009
- Phase
- Observational
- 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 1 day to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: Babies receiving respiratory support, born at 26 weeks and over \& birth weight 700 grams.
Who may be able to join
- Babies receiving respiratory support
Who cannot join
- Parental refusal to be included in the study
- Premature babies under 700 grams birth weight
- Prematurity below 26 weeks gestation
- Severe edematous babies (Hydrops fetalis)
- Severe Hypoxic Ischemic Encephalopathy, initial brain injury or severe intracranial bleeding or major congenital anomalies
- Skin reactions to the adhesive patches
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Monitoring of the Lungs Ventilation Dynamics During Mechanical Ventilation by Small Surface Patches That Include Safe Motion Sensors
Background: Patients that suffer from respiratory failure and need mechanical ventilation are at risk of further deterioration due to complications induced by progression of lung disease or the mechanical ventilation. The complications usually develop in a progressive manner, but are currently detected relatively late, when there is already severe and life threatening deterioration in patient oxygenation and sometimes irreversible damages.
Objective:To measure chest wall dynamics, derived from sensors placed on the chest and abdomen.
Methods: The system comprises of patches attached to the chest wall and upper abdomen that include mechanical sensors that measure the mechanics of lung inflation and deflation.
Read the detailed description
Patients that suffer from respiratory failure and need mechanical ventilation are at risk of further life threatening deterioration following the development of mechanical problems related to airway management, development of lung barotrauma or displacement of the endotracheal tube.
Neonates especially need tight and sensitive monitoring of lung ventilation, because of the high prevalence of lung disease and need for ventilatory support in this population.
Methods:
The system comprises of patches attached to the chest wall and to the epigastrium. The patches include sensors that measure the mechanics of the lung inflation and deflation.
Study protocol
Following parental informed consent, three patches will be placed on both sides of the chest and over the epigastric area in infants that require tight respiratory monitoring.
The patches will be placed just beside the ECG patches. The placement of the patches will be performed by a physician. The monitoring can be preformed as long as the baby needs a tight respiratory monitoring. The patches will be replaced according to routine replacement policy of patches in the neonatal intensive care units, and at the regular time defined by the attending staff, and no longer than 24 hours. At the end of the data acquisition, the patches will be removed.
No additional intervention is required. The patient will be inspected by the supervising physician involve in the research.
It will not provide any data that may alter the treatment and will not interfere or influence the other monitoring devices that are used to evaluate the clinical status of the patient.
The other parameters that are regularly monitored, that are displayed on the bedside monitor and respirator will be recorded by the research assistant. The ventilated baby will be identified by a study number. There will be a separate database for the measurements and the demographic and clinical data. There will be no disclosure of the patient's identity along with the data analysis and publication of the results or communication to authorities or other medical practitioners.
Equipment safety:
The system is safe for the use in human subjects. The whole system is approved for safety according to the acquired standard ICE-60601
- Conditions
- Mechanical Ventilation
- Keywords
- high frequency ventilation monitoring, lung disease, Respiratory distress syndrome, lung barotrauma, mechanical ventilation, endotracheal tube displacement, endotracheal tube occlusion, one lung intubation
- Medical subject headings
- Lung Diseases, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Premature and term newborn infants (male/female) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A data-bank of measured changes in lung dynamics at various clinical settings acquired by the chest sensors.
Secondary outcomes (1)
Detection of changes in lung ventilation by the novel system. Feasibility study. Comparison of the detection made by the novel system to the conventional monitoring methods in use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startDec 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Responsible party
- Principal investigator, Dany Waisman, Carmel Medical Center
- Investigators
- Dan Waisman, MD, Principal investigator, Department of Neonatology Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702169
- Sponsor's protocol ID
- Neo- 01/2006
- Status last verified
- Mar 2022
- First submitted
- 19 Jun 2008
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Monitoring of the Lungs Ventilation Dynamics During Mechanical Ventilation by Small Surface Patches That Include Safe Motion Sensors
- ClinicalTrials.gov ID
- NCT00702169
- Acronym / sponsor ID
- Neo- 01/2006
- Conditions
- Mechanical Ventilation
- Keywords
- high frequency ventilation monitoring, lung disease, Respiratory distress syndrome, lung barotrauma, mechanical ventilation, endotracheal tube displacement, endotracheal tube occlusion, one lung intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Study start
- Dec 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 20 Jun 2008 (estimated)
- 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.
Background: Patients that suffer from respiratory failure and need mechanical ventilation are at risk of further deterioration due to complications induced by progression of lung disease or the mechanical ventilation. The complications usually develop in a progressive manner, but are currently detected relatively late, when there is already severe and life threatening deterioration in patient oxygenation and sometimes irreversible damages.
Objective:To measure chest wall dynamics, derived from sensors placed on the chest and abdomen.
Methods: The system comprises of patches attached to the chest wall and upper abdomen that include mechanical sensors that measure the mechanics of lung inflation and deflation.
Detailed description
Patients that suffer from respiratory failure and need mechanical ventilation are at risk of further life threatening deterioration following the development of mechanical problems related to airway management, development of lung barotrauma or displacement of the endotracheal tube.
Neonates especially need tight and sensitive monitoring of lung ventilation, because of the high prevalence of lung disease and need for ventilatory support in this population.
Methods:
The system comprises of patches attached to the chest wall and to the epigastrium. The patches include sensors that measure the mechanics of the lung inflation and deflation.
Study protocol
Following parental informed consent, three patches will be placed on both sides of the chest and over the epigastric area in infants that require tight respiratory monitoring.
The patches will be placed just beside the ECG patches. The placement of the patches will be performed by a physician. The monitoring can be preformed as long as the baby needs a tight respiratory monitoring. The patches will be replaced according to routine replacement policy of patches in the neonatal intensive care units, and at the regular time defined by the attending staff, and no longer than 24 hours. At the end of the data acquisition, the patches will be removed.
No additional intervention is required. The patient will be inspected by the supervising physician involve in the research.
It will not provide any data that may alter the treatment and will not interfere or influence the other monitoring devices that are used to evaluate the clinical status of the patient.
The other parameters that are regularly monitored, that are displayed on the bedside monitor and respirator will be recorded by the research assistant. The ventilated baby will be identified by a study number. There will be a separate database for the measurements and the demographic and clinical data. There will be no disclosure of the patient's identity along with the data analysis and publication of the results or communication to authorities or other medical practitioners.
Equipment safety:
The system is safe for the use in human subjects. The whole system is approved for safety according to the acquired standard ICE-60601
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Premature and term newborn infants (male/female) |
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Babies receiving respiratory support, born at 26 weeks and over \& birth weight 700 grams.
Key inclusion criteria (1 listed)
- Babies receiving respiratory support
Key exclusion criteria (6 listed)
- Parental refusal to be included in the study
- Premature babies under 700 grams birth weight
- Prematurity below 26 weeks gestation
- Severe edematous babies (Hydrops fetalis)
- Severe Hypoxic Ischemic Encephalopathy, initial brain injury or severe intracranial bleeding or major congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A data-bank of measured changes in lung dynamics at various clinical settings acquired by the chest sensors.
1 secondary outcome
Detection of changes in lung ventilation by the novel system. Feasibility study. Comparison of the detection made by the novel system to the conventional monitoring methods in use.
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 29 Mar 2022.
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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.
Dan Waisman, MD principal investigator
Department of Neonatology Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation, run by Carmel Medical Center at 1 site in Israel.
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 1 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 29 Mar 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 Israel. 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?
A data-bank of measured changes in lung dynamics at various clinical settings acquired by the chest sensors.. 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 29 Mar 2022.