ClinicalTrials.gg
Status unknownNCT01379820Updated Jun 23, 2011

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

A Phase 2/3 interventional study of OROTRACHEAL cpap WITH COMPENSATION BAG ( GREGORY CPAP) in Neonatal Respiratory Failure, sponsored by Hospital Angeles del Pedregal. Status unknown. Open to participants aged 1 Minute and older. Per ClinicalTrials.gov, last updated 2011-06-23.

Sponsored by Hospital Angeles del Pedregal · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
1 Minute and older
Sex
All
01

Study 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 .

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 .

02

Conditions studied

  • Neonatal Respiratory Failure

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Keywords

  • NEONATAL RESPIRATORY FAILURE
  • OROTRACHEAL cpap
  • NASAL cpap
  • MECHANICAL VENTILATION
  • PNEUMOTHORAX
  • COMPENSATION BAG
03

In context

Pneumothorax

183 studies on the registry are indexed under Pneumothorax; 41 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 111 interventional studies indexed under Pneumothorax.

Browse Pneumothorax studies →

Lead sponsor

Hospital Angeles del Pedregal is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Minute and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • newborns without respiratory disease or 33 week of gestational age or more.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Interventions

  • DeviceOROTRACHEAL cpap WITH COMPENSATION BAG ( GREGORY CPAP)

    USE OF OROTRACHEAL CPAP FOR RESPIRATORY DISTRESS SYNDROME IN NEWBORNS .

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 36 weeks of gestational age

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2011, a primary completion of Jun 2011 and a completion of Jun 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 22, 2011
First posted
Jun 23, 2011
Start
Jun 2011
Primary completionActual
Jun 2011
CompletionEst.
Jun 2011
Last update
Jun 23, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01379820
Lead sponsor
Hospital Angeles del Pedregal
First posted
Jun 23, 2011
Start date
Jun 2011
Primary completion
Jun 2011
Completion
Jun 2011 (estimated)
Last update
Jun 23, 2011

Study contacts

alberto orozco, md
Contact
drorozco55@hotmail.com
525555684091

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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