search
Back to results

Use of Orotracheal Continuous Positive Airway Pressure (CPAP) in Newborns With Respiratory Failure

Primary Purpose

Neonatal Respiratory Failure

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
OROTRACHEAL cpap WITH COMPENSATION BAG ( GREGORY CPAP)
Sponsored by
Hospital Angeles del Pedregal
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Respiratory Failure focused on measuring NEONATAL RESPIRATORY FAILURE, OROTRACHEAL cpap, NASAL cpap, MECHANICAL VENTILATION, PNEUMOTHORAX, COMPENSATION BAG

Eligibility Criteria

1 Minute - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • newborns with respiratory disease preterm less 32 week of gestational age.

Exclusion Criteria:

  • newborns without respiratory disease or 33 week of gestational age or more.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    infections rate, failure to treatment , other complications.
    we compare infections rate, failure to treatment , other complications. in all the groups

    Full Information

    First Posted
    June 22, 2011
    Last Updated
    June 22, 2011
    Sponsor
    Hospital Angeles del Pedregal
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01379820
    Brief Title
    Use of Orotracheal Continuous Positive Airway Pressure (CPAP) in Newborns With Respiratory Failure
    Official Title
    Use of Orotracheal CPAP ( Gregory System) for Treatment of Respiratory Failure in Newborns
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    June 2011 (Actual)
    Study Completion Date
    June 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hospital Angeles del Pedregal

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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 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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neonatal Respiratory Failure
    Keywords
    NEONATAL RESPIRATORY FAILURE, OROTRACHEAL cpap, NASAL cpap, MECHANICAL VENTILATION, PNEUMOTHORAX, COMPENSATION BAG

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    OROTRACHEAL cpap WITH COMPENSATION BAG ( GREGORY CPAP)
    Intervention Description
    USE OF OROTRACHEAL CPAP FOR RESPIRATORY DISTRESS SYNDROME IN NEWBORNS .
    Primary Outcome Measure Information:
    Title
    mortality. pneumothorax , oxygen at 36 weeks of gestational age
    Description
    we compare mortality. pneumothorax , oxygen at 36 weeks of gestational age in all the groups , mechanical ventilation , Nasal CPAP and orotracheal CPAP
    Time Frame
    at 36 weeks of gestational age
    Secondary Outcome Measure Information:
    Title
    infections rate, failure to treatment , other complications.
    Description
    we compare infections rate, failure to treatment , other complications. in all the groups
    Time Frame
    36 weeks of gestational age

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Minute
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: newborns with respiratory disease preterm less 32 week of gestational age. Exclusion Criteria: newborns without respiratory disease or 33 week of gestational age or more.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    alberto orozco, md
    Phone
    525555684091
    Email
    drorozco55@hotmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Use of Orotracheal Continuous Positive Airway Pressure (CPAP) in Newborns With Respiratory Failure

    We'll reach out to this number within 24 hrs