Ignite Creation Date:
2024-05-06 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03159039
Status:
COMPLETED
Last Update Posted:
2018-03-15
First Post:
2017-04-06
Brief Title:
Repercussions of Respiratory Physiotherapy in Preterm Infants Under Mechanical Ventilation
Sponsor:
Universidade Cidade de Sao Paulo
Organization:
Universidade Cidade de Sao Paulo
Study Overview
Official Title:
Study of Clinical Repercussions of Conventional Respiratory Physiotherapy Versus Prolonged Slow Expiration in Preterms Under Mechanical Ventilation
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
preterm
Brief Summary:
Respiratory diseases are a major morbidity and mortality causes of neonatal requiring mechanical ventilation especially in newborn preterm infants PN thus respiratory therapy becomes increasingly necessary in order to minimize the effects of complications and improve respiratory functions increasing mucociliary transport with techniques that consist of manual maneuvers to bronchial hygiene such as vibro associated with postural drainage and prolonged slow exhalation Objective To compare and analyze the effects of convensional physiotherapy CP versus prolonged slow exhalation PSE in heart rate HR and respiratory rate RR O2 saturation SpO2 and Tidal Volume TV time permanence of mechanical ventilation TMV and number of extubation failure EF in premature infants on mechanical ventilation MV Methods Randomized clinical trial conducted in the neonatal intensive care unit of the General Hospital Itapecerica da Serra Seconci OSS SP comparing two physical therapy techniques applied to preterm infants on mechanical ventilation
Detailed Description:
Neonates patients admitted at unit of Intensive Care of Geral Hospital of Itapecerica da Serra São Paulo-Brazil will recruited to this study Based on World Health Organization WHO the neonates preterm are those who present gestational age GA 35 weeks gestational age was calculated based on the date of last menstruation Inclusion criteria neonates born at GA35 weeks under mechanical ventilation interplus 5 -Intermédica or servo i Maquet Solvan Sweden for the first 7 days of life hemodynamically stable birth weight 1500 gram per cent change inspired oxygen received FiO2 06 Inspiratory pressure 25 cmH2O medical prescription of chest physiotherapy Exclusion criteria congenital malformation graves genetic syndromes and situations pulmonary hypertension peri-intraventricular hemorrhage and coagulopathies
All patients will receive chest physiotherapy when it is necessary and all of them will monitored until dischange
After performed all included criteria patients will randomized in 2 groups group CCP patients submitted to conventional chest physiotherapy techniques or group PSE patients submitted to prolonged slow exhalation technique
After that for both group physiotherapist take note of gestacional age gender bith weight gram Apgar score 1º 5º and 10º minute type of delivery medical diagnosis mechanical ventilation parameters medications Then lung auscultation breathing pattern pulse oximetry and radiological chest pattern of all patients will evaluated by the same physiotherapist
CCP group n22 patients will submitted to a postural drainage associated with manual vibration They will positionated with left or right of ribcage to up and then physiotherapist made a manual vibratory movements associated with a mild compression in ribcage at the end of expiratory phase The technique was made during 5 minutes in each side After that endotraqueal aspiration will performed
PSE group n21 patients will carefully positionated with head up 30º and then physiotherapist put one hand around ribcage area e another in abdominal area then he made a mild pressure in both areas at the same time in the end of expiratory phase of patient until residual volume keeping the pressure for 2 seconds This technique will made during 10 minutesAt the end endotraqueal aspiration will perfomed
Both techniques will realized with the same physiotherapist 2 times a day morning and afternoon during 10 minutes and all data were recorded during the 2 first days of physiotherapy assistance
During the protocol the follow data will recorded respiratory rate digital timer C4539-Brady Brazil heart rate and peripheral oxygen saturation multiparameter monitor DX 2010 -Dixtal Biomédica Brazil exhaled tidal volume internal sensor ventilation mechanical number of days under mechanical ventilation and number of fail times in extubation These parameters will recorded in 5 diferent moments T0 before beginning of physiotherapyT1 immediately after physiotherapy technique T2 immediately after cannula aspiration T3 after 5 minutes of all procedures T4 20 minutes after all procedures
All patients will receive chest physiotherapy when it is necessary and all of them will monitored until dischange
After performed all included criteria patients will randomized in 2 groups group CCP patients submitted to conventional chest physiotherapy techniques or group PSE patients submitted to prolonged slow exhalation technique
After that for both group physiotherapist take note of gestacional age gender bith weight gram Apgar score 1º 5º and 10º minute type of delivery medical diagnosis mechanical ventilation parameters medications Then lung auscultation breathing pattern pulse oximetry and radiological chest pattern of all patients will evaluated by the same physiotherapist
CCP group n22 patients will submitted to a postural drainage associated with manual vibration They will positionated with left or right of ribcage to up and then physiotherapist made a manual vibratory movements associated with a mild compression in ribcage at the end of expiratory phase The technique was made during 5 minutes in each side After that endotraqueal aspiration will performed
PSE group n21 patients will carefully positionated with head up 30º and then physiotherapist put one hand around ribcage area e another in abdominal area then he made a mild pressure in both areas at the same time in the end of expiratory phase of patient until residual volume keeping the pressure for 2 seconds This technique will made during 10 minutesAt the end endotraqueal aspiration will perfomed
Both techniques will realized with the same physiotherapist 2 times a day morning and afternoon during 10 minutes and all data were recorded during the 2 first days of physiotherapy assistance
During the protocol the follow data will recorded respiratory rate digital timer C4539-Brady Brazil heart rate and peripheral oxygen saturation multiparameter monitor DX 2010 -Dixtal Biomédica Brazil exhaled tidal volume internal sensor ventilation mechanical number of days under mechanical ventilation and number of fail times in extubation These parameters will recorded in 5 diferent moments T0 before beginning of physiotherapyT1 immediately after physiotherapy technique T2 immediately after cannula aspiration T3 after 5 minutes of all procedures T4 20 minutes after all procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None