Chest Physiotherapy Technique Increasing Inspiratory Flow on Weaning From Non Invasive Ventilation
Condition: Neonatal Respiratory Distress Syndrome; Intubation, Intratracheal
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Aspiration; Hyaline Membrane Disease
Study type: Interventional

Summary: 
      The main objective is to show by a randomised controled therapeutic trial comparing in two
      parallel open arms ( 50 infants x 2 = 100 infants) that the technique IIF decreases the
      duration of non invasive respiratory support in the group treated by chest physiotherapy as
      compared to the control group. The secondary objectives are to evaluate the duration of
      oxygen dependence, the duration of hospitalisation and the proportional advent of
      bronchopulmonary dysplasia.

      These study will be conducted in patients less than 32 weeks post menstrual age, eutrophic,
      treated by non invasive respiratory support after weaning off from mechanical endotracheal
      ventilation benefitting form a social security system and for whom the appropriate parental
      authority are non opposed.
    

Detailed description: 
      The treatment evaluated is the contribution of the chest physiotherapy technique of
      increasing the inspiratory flow (IIF) administered 3 times per day for a duration of 3 to 10
      minutes according to the tolerance of the infant and interrupted if required by periods of
      rest. This technique utilises the exclusive nasal respiration and the increased thoracic
      compliance of the premature infant. The physiotherapy practiced engenders a progressive
      increase in the inspiratory flow until the physiological limits of the infant (expired volume
      and clinical tolerance). After having assured that the system is well in place, during the
      following inspiration we close the infant's mouth in a manner to add the following two
      simultaneous parameters of ventilation: forced inspiration and the PEP delivered by the
      ventilator. Regarding the Bi-phasic Positive Airway Pressure system of non invasive
      ventilation which is triggered by a movement captor placed on the skin of the lower thoracic
      cage, the physiotherapist will generate a first forced inspiration by following the
      respiratory rhythm of the infant. The infant will thus trigger the inspiratory aid of his
      machine simultaneously with the PEP delivered and the forced provoked inspiration.The
      respiratory rate of the infant can however be underestimated by the machine as it may not
      detect the ineffective respiratory efforts. The physiotherapy session shall be carried out by
      a physiotherapist of the service trained in this technique assisted by a nurse and the
      treatment shall start in the 24 hours following extubation/ weaning off form mechanical
      ventilation. The evaluation of clinical improvement will be done on a daily basis and the
      mode of non invasive respiratory support adapted accordingly. The objective of the project is
      to show that chest physiotherapy permits to decrease the duration of non invasive ventilation
      in the treatment group as compared to a control group without the above treatment ( this
      group will receive the usual care without the chest physiotherapy after extubation). Along
      with the expected diminution of the duration of non invasive respiratory support , we will
      also evaluate the efficiency of the IIF technique on the duration of oxygen dependence, the
      duration of hospitalisation of the premature infant on the special care unit, the proportion
      of infants diagnosed as having bronchopulmonary dysplasia at 36 weeks post menstrual age as
      established by the WALSH test as well as the presence of atelectasis on the chest X ray done
      within the 7 days following extubation. Eventual nociceptive effect will be evaluated by a
      pain score realised during the session.

      This is a randomised controled therapeutic trial comparing two open parallel groups:

        -  A treatment group benefitting from the chest physiotherapy technique increasing
           inspiratory flow (IIF) 3 times per day along with the usual surveillance carried out
           under non invasive ventilation.

        -  A control group having the usual surveillance carried out under non invasive ventilation
           without any chest physiotherapy.

      The research shall be carried out in one center. A draw to assign or not to the treatment
      group will be carried out by the physiotherapist present after having received the
      eligibility for the infant. The randomisation will be done by the physiotherapist with the
      aid of the electronic database CLEANWEB according to a list of pre established balanced
      randomisation ( size of the blocks not divulged to the investigators or the physiotherapists)
      after verification of the criteria of inclusion and information and explanation of the
      protocol to the parents.

      Duration of inclusion: 24 months Duration of participation of each infant: 4 months maximum
      of treatment with follow up till discharge.

      Duration of the research: 28 months Randomisation shall be done in the 24 hours following
      extubation. At all times the investigator can interrupt the study prematurely for a medical
      or administrative reason. In all cases the early termination will be done only after mutual
      discussion and appropriate documentation of the motives ( for example a letter of abandon for
      the investigator) and the investigator will inform the CPP.

      If they want, the parental authority holders can at all times opt against the participation
      of their child in the study. In that case unless specifically desired otherwise, the data
      obtained during the inclusion of their child will be analysed This withdrawal from the study
      will not change the quality of the clinical management of their infant.

      A termination of the study can be considered in case of insufficient recruitment, unresolved
      technical problems, expressed desire of the investigator or repeated and unjustified
      violation of the protocol.

      In the setting of pathologies which might put at stake the vital prognostic of the patients a
      Surveillance Committee has been established to be able to:

        -  Follow the distribution of these events in the two arms of the study to make sure that
           there is no imbalance between the two.

        -  Make appropriate recommendations if need be (Eg: modification of the protocol ;
           continuation, suspension or early termination of the study etc. )"
    

Intervention name(s): Chest physiotherapy; Usual surveillance
Intervention type(s): Procedure; Procedure
Intervention description(s): Usual surveillance of the non invasive ventilation without chest physiotherapy.
Other intervention name(s): Increased inspiratory flow technique (IIF)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Chest; Physiotherapy; Increased Inspiratory Flow Technique; Prematurity; Non Invasive Ventilation