Neonatal Respiratory FailurePhase 2/3NCT01379820
Use of Orotracheal Continuous Positive Airway Pressure (CPAP) in Newborns With Respiratory Failure
A Phase 2/3 study testing OROTRACHEAL cpap WITH COMPENSATION BAG ( GREGORY CPAP) in people with Neonatal Respiratory Failure, run by Hospital Angeles del Pedregal.
Trial summary
Nasal CPAP is a excellent ventilation modality for newborns, but the incidence of pneumothorax is high (65.% - 9%) our hypothesis is when the baby open the mouth or crie the pressure in the airway is variable, the investigators evaluate a closed system with a intubated baby with a orotracheal system but with a elastic… Read more about this study
- Who is it for?
- Ages 1 minute and older
- Conditions the study is for
- Neonatal Respiratory Failure
- What is being tested?
- OROTRACHEAL cpap WITH COMPENSATION BAG ( GREGORY CPAP)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jun 2011
- Phase
- Phase 2/3
- 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 minute and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- newborns with respiratory disease preterm less 32 week of gestational age.
Who cannot join
- newborns without respiratory disease or 33 week of gestational age or more.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Use of Orotracheal CPAP ( Gregory System) for Treatment of Respiratory Failure in Newborns
Nasal CPAP is a excellent ventilation modality for newborns, but the incidence of pneumothorax is high (65.% - 9%) our hypothesis is when the baby open the mouth or crie the pressure in the airway is variable, the investigators evaluate a closed system with a intubated baby with a orotracheal system but with a elastic reservoir , the reservoir distend and the pressure in the airway is constant ,with this system the investigators protect the lungs for damage . The investigators want compare the use of nasal CPAP, mechanical ventilation and orotracheal CPAP with a compensation bag (gregory system) in newborns with respiratory failure .
Read the detailed description
Recent advances in the intensive care of the newborns are closely related to the evolution in the management of the respiratory distress syndrome (RDS) frequently associated with lung immaturity specially in the premature infant as well as with various pathological conditions in the mature lung of the full- term baby. The methods of ventilatory assistance to treat these conditions vary from continuous positive airway pressure (CPAP) to conventional mechanical ventilation and/or high frequency ventilation. It is reasonable to assume that the type of ventilatory assistance provided to these infants should be graded in accordance to the severity of the respiratory problem (1) therefore the mode of respiratory support should be one which while providing adequate ventilatory assistance will result in minimal volu or barotrauma.
Currently the investigators know that the best ventilatory technique is one that stabilizes Po2, Pco2 and Ph and avoids volu and barotrauma, diminishes the possibility of pulmonary injury and shortens the time spent in the hospital.
It has been demonstrated that with the use of CPAP the need for mechanical ventilation is less and that the possibility of pulmonary injury and the length of hospital stay are shortened (1 ) ( 2). The need to use mechanical ventilation increases when gestational age is marginal or in the presence of severe pulmonary pathology that causes increased respiratory problems which in turn enhances the possibility of increase the alveolar oxygen tension gradient (A-a DO2) to more then 180mmHg and to cause the presence of a more severe hyaline membrane syndrome as evidenced by sequential chest X rays (8). This also will limit the need for early nasal continuous airway pressure (ENCPAP). Other limiting factors could be pressure changes due to physiological events such as cry, mouth open or close, cough or hippus. In the past use CPAP generated by the ventilator administered via an endotracheal cannula ; however this method of ventilation has been abandoned due to the high risk of barotrauma due to the surges of pression in a closed, rigid, system that could eventually generate an increased resistance due to the disparity between the caliber of the endotracheal tube and that of the trachea (9). This increased resistance was for a long time considered to be a great limiting risk for the use of orotracheal CPAP particularly in premature infants.
According with the severity of the disease, the best results have been obtained with the use of low pressure, high pulmonary volumes such as those provided by high frequency oscillatory ventilation (HFOV) or conventional ventilation with a high positive end expiration pressure (PEEP) (1).
The investigators want determinate the rate of pneumothorax , use of oxygen at 36 weeks of gestational age , failure to treatment, mortality , infection rate an other complications with the 3 methods for assisted ventilation.
The concept of The Compensation Bag (accessory lung):
This concept is based on the gregory original work in 1972 (3) , the investigators postulate that the air pressure in a closed airway circuit always tries to find a way to escape, in this situation, the weakest point in this close circuit is the alveolus, therefore any variation in pressure will be directly reflected in the intrinsic alveolar pressure, that is, if there is a fall in the circuit pressure the intra-alveolar pressure will fall, causing in turn a decrease in the alveolar oxygen tension gradient which will cause a collapse of the alveolar sac. On the other hand an increase in the pressure of the airway circuit will augment the intra-alveolar pressure, distending the sac, causing inflammatory changes on its wall and eventually rupturing it occasioning air leakage and on the long run giving raise to pathological sequels such as bronchopulmonary dysplasia.
The compensation bag is fitted with a distensible mechanical valve which is interposed in the closed circuit, so that in case of an increase in pressure the distention point will be the bag and not the alveolus. Also in case of a decreased in pressure the point of collapse is the bag therefore preventing a collapse of the alveolar sac, this allows to maintain an optimally expanded alveolus without the risk of over distention or collapse. At the same time the pulmonary resistance occasioned by the endotracheal tube is regulated within the circuit thus improving the performance of the mechanical ventilation through a better alveolar expansion and a more adequate alveolar oxygen tension, avoiding sudden pressure variations but maintaining the benefit of conventional CPAP keeping a constant alveolar volume regardless of any physiological event.
In 1972 the Gregory work report excellent evolution with the use of a anesthestic bag for ventilation in newborns, in 2009 , the investigators reported a small study with a modified gregory system with excellent evolution . (4) in this work the investigators want report the use of this system in more babies .
- Conditions
- Neonatal Respiratory Failure
- Being tested
- OROTRACHEAL cpap WITH COMPENSATION BAG ( GREGORY CPAP)
- Keywords
- NEONATAL RESPIRATORY FAILURE, OROTRACHEAL cpap, NASAL cpap, MECHANICAL VENTILATION, PNEUMOTHORAX, COMPENSATION BAG
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OROTRACHEAL cpap WITH COMPENSATION BAG ( GREGORY CPAP)Device
USE OF OROTRACHEAL CPAP FOR RESPIRATORY DISTRESS SYNDROME IN NEWBORNS .
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality. pneumothorax , oxygen at 36 weeks of gestational age
we compare mortality. pneumothorax , oxygen at 36 weeks of gestational age in all the groups , mechanical ventilation , Nasal CPAP and orotracheal CPAP
Measured: at 36 weeks of gestational age
Secondary outcomes (1)
infections rate, failure to treatment , other complications.
we compare infections rate, failure to treatment , other complications. in all the groups
Measured: 36 weeks of gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2011
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory FailureStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Angeles del Pedregal
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379820
- Sponsor's protocol ID
- 01/2008
- Status last verified
- Jun 2011
- First submitted
- 22 Jun 2011
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Orotracheal CPAP ( Gregory System) for Treatment of Respiratory Failure in Newborns
- ClinicalTrials.gov ID
- NCT01379820
- Acronym / sponsor ID
- 01/2008
- Conditions
- Neonatal Respiratory Failure
- Keywords
- NEONATAL RESPIRATORY FAILURE, OROTRACHEAL cpap, NASAL cpap, MECHANICAL VENTILATION, PNEUMOTHORAX, COMPENSATION BAG
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Angeles del PedregalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (estimated)
- First posted
- 23 Jun 2011 (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.
Nasal CPAP is a excellent ventilation modality for newborns, but the incidence of pneumothorax is high (65.% - 9%) our hypothesis is when the baby open the mouth or crie the pressure in the airway is variable, the investigators evaluate a closed system with a intubated baby with a orotracheal system but with a elastic reservoir , the reservoir distend and the pressure in the airway is constant ,with this system the investigators protect the lungs for damage . The investigators want compare the use of nasal CPAP, mechanical ventilation and orotracheal CPAP with a compensation bag (gregory system) in newborns with respiratory failure .
Detailed description
Recent advances in the intensive care of the newborns are closely related to the evolution in the management of the respiratory distress syndrome (RDS) frequently associated with lung immaturity specially in the premature infant as well as with various pathological conditions in the mature lung of the full- term baby. The methods of ventilatory assistance to treat these conditions vary from continuous positive airway pressure (CPAP) to conventional mechanical ventilation and/or high frequency ventilation. It is reasonable to assume that the type of ventilatory assistance provided to these infants should be graded in accordance to the severity of the respiratory problem (1) therefore the mode of respiratory support should be one which while providing adequate ventilatory assistance will result in minimal volu or barotrauma.
Currently the investigators know that the best ventilatory technique is one that stabilizes Po2, Pco2 and Ph and avoids volu and barotrauma, diminishes the possibility of pulmonary injury and shortens the time spent in the hospital.
It has been demonstrated that with the use of CPAP the need for mechanical ventilation is less and that the possibility of pulmonary injury and the length of hospital stay are shortened (1 ) ( 2). The need to use mechanical ventilation increases when gestational age is marginal or in the presence of severe pulmonary pathology that causes increased respiratory problems which in turn enhances the possibility of increase the alveolar oxygen tension gradient (A-a DO2) to more then 180mmHg and to cause the presence of a more severe hyaline membrane syndrome as evidenced by sequential chest X rays (8). This also will limit the need for early nasal continuous airway pressure (ENCPAP). Other limiting factors could be pressure changes due to physiological events such as cry, mouth open or close, cough or hippus. In the past use CPAP generated by the ventilator administered via an endotracheal cannula ; however this method of ventilation has been abandoned due to the high risk of barotrauma due to the surges of pression in a closed, rigid, system that could eventually generate an increased resistance due to the disparity between the caliber of the endotracheal tube and that of the trachea (9). This increased resistance was for a long time considered to be a great limiting risk for the use of orotracheal CPAP particularly in premature infants.
According with the severity of the disease, the best results have been obtained with the use of low pressure, high pulmonary volumes such as those provided by high frequency oscillatory ventilation (HFOV) or conventional ventilation with a high positive end expiration pressure (PEEP) (1).
The investigators want determinate the rate of pneumothorax , use of oxygen at 36 weeks of gestational age , failure to treatment, mortality , infection rate an other complications with the 3 methods for assisted ventilation.
The concept of The Compensation Bag (accessory lung):
This concept is based on the gregory original work in 1972 (3) , the investigators postulate that the air pressure in a closed airway circuit always tries to find a way to escape, in this situation, the weakest point in this close circuit is the alveolus, therefore any variation in pressure will be directly reflected in the intrinsic alveolar pressure, that is, if there is a fall in the circuit pressure the intra-alveolar pressure will fall, causing in turn a decrease in the alveolar oxygen tension gradient which will cause a collapse of the alveolar sac. On the other hand an increase in the pressure of the airway circuit will augment the intra-alveolar pressure, distending the sac, causing inflammatory changes on its wall and eventually rupturing it occasioning air leakage and on the long run giving raise to pathological sequels such as bronchopulmonary dysplasia.
The compensation bag is fitted with a distensible mechanical valve which is interposed in the closed circuit, so that in case of an increase in pressure the distention point will be the bag and not the alveolus. Also in case of a decreased in pressure the point of collapse is the bag therefore preventing a collapse of the alveolar sac, this allows to maintain an optimally expanded alveolus without the risk of over distention or collapse. At the same time the pulmonary resistance occasioned by the endotracheal tube is regulated within the circuit thus improving the performance of the mechanical ventilation through a better alveolar expansion and a more adequate alveolar oxygen tension, avoiding sudden pressure variations but maintaining the benefit of conventional CPAP keeping a constant alveolar volume regardless of any physiological event.
In 1972 the Gregory work report excellent evolution with the use of a anesthestic bag for ventilation in newborns, in 2009 , the investigators reported a small study with a modified gregory system with excellent evolution . (4) in this work the investigators want report the use of this system in more babies .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 1 minute and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- newborns with respiratory disease preterm less 32 week of gestational age.
Key exclusion criteria (1 listed)
- newborns without respiratory disease or 33 week of gestational age or more.
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 |
|---|---|---|
| OROTRACHEAL cpap WITH COMPENSATION BAG ( GREGORY CPAP)USE OF OROTRACHEAL CPAP FOR RESPIRATORY DISTRESS SYNDROME IN NEWBORNS . | Device | – |
Primary outcome
mortality. pneumothorax , oxygen at 36 weeks of gestational age
Time frame: at 36 weeks of gestational age
we compare mortality. pneumothorax , oxygen at 36 weeks of gestational age in all the groups , mechanical ventilation , Nasal CPAP and orotracheal CPAP
1 secondary outcome
infections rate, failure to treatment , other complications.
Time frame: 36 weeks of gestational age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
Related trials for Neonatal Respiratory Failure
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Respiratory Progression in Adults With Duchenne Muscular Dystrophy.
Duchenne Muscular Dystrophy (DMD), Respiratory Function Decline
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing OROTRACHEAL cpap WITH COMPENSATION BAG ( GREGORY CPAP) in people with Neonatal Respiratory Failure, run by Hospital Angeles del Pedregal.
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 1 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 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 alberto orozco, md (525555684091, drorozco55@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality. pneumothorax , oxygen at 36 weeks of gestational age (time frame: at 36 weeks of gestational age). 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 23 Jun 2011.