Intubation, Intratracheal Clinical Trial
— KVNIOfficial title:
Evaluating the Impact of Chest Physiotherapy Technique Increasing Inspiratory Flow on Weaning From Non Invasive Ventilation (KVNI) Pilot Study
Verified date | April 2017 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 101 |
Est. completion date | April 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 24 Weeks to 32 Weeks |
Eligibility |
Inclusion Criteria: - Infants < 32 weeks post menstrual age (corrected gestational age) and eutrophic on the AUDIPOG charts - Patients with non invasive ventilation/ respiratory support following weaning from mechanical endo tracheal ventilation. - Information letter given to the appropriate parental authority. - Prior medical evaluation. - Affiliation with a social security system. Exclusion Criteria: - Pneumothorax, emphysema, reintubation within 24 hours. - Small for gestational age as defined by a birth weight < 10th percentile on the AUDIPOG charts. - Intraventricular hemorrhage grade 3 and 4 (VOLPE's classification- (32-33)) - Thrombopenia (Platelet count < 80 000/mm3) - Malformative syndromes |
Country | Name | City | State |
---|---|---|---|
France | AP-HP, Antoine Béclère Hospital | Clamart |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of days of non invasive respiratory support post extubation | Data noted till discharge from special care (baby ) unit (4 months) | ||
Secondary | Duration of oxygen dependence. | Data noted till discharge from special care (baby ) unit (4 months) | ||
Secondary | Duration of hospitalisation of the premature infant on the special care unit | 4 months | ||
Secondary | bronchopulmonary dysplasia 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 | at 36 weeks post menstrual age | ||
Secondary | Pain score realised during the session | Eventual nociceptive effect | until 4 months |
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