Intubation, Intratracheal Clinical Trial
Official title:
Evaluating the Impact of Chest Physiotherapy Technique Increasing Inspiratory Flow on Weaning From Non Invasive Ventilation (KVNI) Pilot Study
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.
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. )"
;
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