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NCT Number: NCT03551314

Effects of Two Modalities of Non-invasive Ventilation After Extubation in Very Low Birth Weight Neonates

The objective of this study is to evaluate the effects of continuous positive airway pressure and nasal intermittent positive pressure ventilation on breathing pattern variables of very low birth weight neonates immediately after extubation.

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Key information

Conditions

Preterm Infant Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas da UFMG, Belo Horizonte, Minas Gerais, Brazil

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About this study

The effects of non-invasive ventilation on the respiratory function of neonates have not been fully elucidated. Currently, two modalities of non invasive ventilation are commonly used in Brazilian neonatal intensive care units: continuous positive airway pressure (CPAP) and nasal intermittent positive pressure ventilation (NIPPV). In this study, it was hypothesized that NIPPV will improve tidal volume when compared to CPAP. The objective of this study is to evaluate the effects of continuous positive airway pressure and nasal intermittent positive pressure ventilation on breathing pattern variables of very low birth weight neonates immediately after extubation. Soon after extubation, the neonates will be randomized into the CPAP-NIPPV (sequence 1) or the NIPPV-CPAP (sequence 2). The sequence will be assigned at random using sealed envelopes. Respiratory inductive plethysmography will be used to evaluate the breathing pattern (tidal volume, respiratory rate, minute ventilation, mean inspiratory flow) and chest wall motion (labor breathing index, inspiratory phase relation, expiratory phase relation, total phase relation and phase angle). Student t tests for paired samples will be used and the Wilcoxon test according to the data distribution. A significance level of 5% will be adopted. The analyzes will be performed by StatisticalPackage software for the Social Sciences® (SPSS, Chicago, IL, USA), version 17.0 for Windows.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presented gestational age less than or equal to 32 weeks and weight less than or equal to 1,500 g;
  • Stability from an hemodynamic point of view (without use of amines);
  • Have undergone invasive mechanical ventilation;
  • Absence of congenital heart diseases and / or other congenital anomalies (myelomeningocele, gastroschisis and / or omphalocele) or chromosomal abnormalities;
  • Absence of any condition that requires surgery in the neonatal period.

Exclusion criteria

  • Presented air leak syndrome (pneumothorax, pneumomediastinum); upper airway obstruction after extubation and non-scheduled extubation.

Treatment and study plan

Nasal Intermittent Positive Pressure

Other
  • NIPPV The following parameters: inspiratory pressure = 15 cmH2O / final expiratory positive pressure = 6 cmH2O / inspiratory time = 0.40 / flow = 6-8 L.min-1 / respiratory rate = 24.

Respiratory inductive plethysmography is used to evaluate breathing pattern (tidal volume, respiratory rate, minute ventilation, mean inspiratory flow) and chest wall motion (labor breathing index - LBI, phase relation in inspiratory breathing - PhRIB, phase relation in expiratory breathing - PhREB, total phase relation - PhRTB and phase angle).

Continuous Positive Airway Pressure

Other
  • CPAP The following parameters: pressure of 6 cmH2O, with flow of 6-8L/min.

Respiratory inductive plethysmography is used to evaluate breathing pattern (tidal volume, respiratory rate, minute ventilation, mean inspiratory flow) and chest wall motion (labor breathing index - LBI, phase relation in inspiratory breathing - PhRIB, phase relation in expiratory breathing - PhREB, total phase relation - PhRTB and phase angle).

Primary outcomes

  1. Tidal volume

    Time frame: Measure during the two non-invasive ventilation strategies. Tidal volume will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.

    Defined as the volume of air entering or exiting the lungs during each breath - in millilitres.

Secondary outcomes

  1. Respiratory rate

    Time frame: Measure during the two non-invasive ventilation strategies. Respiratory rate will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.

    Breaths per minute

  2. Minute ventilation

    Time frame: Measure during the two non-invasive ventilation strategies. Minute ventilation will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.

    Computed from tidal volume multiplied by respiratory rate, in liters/minute

  3. Mean inspiratory flow

    Time frame: Measure during the two non-invasive ventilation strategies. Mean inspiratory flow will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.

    Is a estimation of respiratory center drive activity. The higher its value, the greater the drive and vice-versa.

  4. Labored Breathing Index (LBI)

    Time frame: Measure during the two non-invasive ventilation strategies. Labor breathing index (LBI) will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.

    This is a measure of chest wall coordination. This is the Labored Breathing Index (LBI) of a breath that takes into account phase and amplitude of the ribcage and abdomen traces. It is computed as the ratio of the sum of the integrals of the absolut values of the derivatives of the inspiratory limbs of ribcage and abdomen excursions divided by the corresponding integral of the derivative of the inspiratory limb of the tidal volume deflection. This measure of thoracoabdominal coordination is computed on a breath by breath basis. Perfect thoracoabdominal coordination produces an LBI of 1.0. In babies or adults who are relaxed and awake or in Quiet State, LBI lies between 1.0 and 1.2 but no systematic study of the normal values of LBI as a function of sleep stage and body posture has yet been undertaken. In Active State, thoracoabdominal discoordination generally is associated with elevated LBI values.

  5. Phase relation in inspiratory breathing (PhRIB)

    Time frame: Measure during the two non-invasive ventilation strategies. Phase relation in inspiratory breathing will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.

    This express the percentage agreement between direction of ribcage and abdomen movements during the inspiratory phase of breath.

  6. Phase relation in expiratory breathing

    Time frame: Measure during the two non-invasive ventilation strategies. Phase relation in expiratory breathing will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.

    This express the percentage agreement between direction of ribcage and abdomen movements during the expiratory phase of breath.

  7. Phase relation in total breathing

    Time frame: Measure during the two non-invasive ventilation strategies. Phase relation in total breathing will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.

    This express the percentage agreement between direction of ribcage and abdomen movements during the entire breath cycle.

  8. Phase angle

    Time frame: Measure during the two non-invasive ventilation strategies. Phase angle will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.

    The phase angle is computed from Lissajous loops between ribcage and abdomen excursions on a breath by breath basis.

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

Effects of Two Modalities of Non-invasive Ventilation on Breathing Pattern Variables of Preterm Neonates of Very Low Weight After Extubation

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 11, 2018
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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