Repercussions of Respiratory Physiotherapy in Preterm Infants Under Mechanical Ventilation
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional

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 GA<35 weeks, under mechanical ventilation (interplus 5 -Intermédica® or servo i (Maquet,
      Solvan, Sweden) for the first 7 days of life, hemodynamically stable; birth weight ≤1.500
      gram; per cent change inspired oxygen received (FiO2) ≤ 0.6; 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 (n=22): 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 (n=21): 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
      minutes.At 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
      physiotherapy);T1 (immediately after physiotherapy technique); T2 (immediately after cannula
      aspiration); T3 (after 5 minutes of all procedures); T4 (20 minutes after all procedures).
    

Intervention name(s): Conventional Physiotherapy; Prolonged slow exhalation technique
Intervention type(s): Other; Other
Intervention description(s): Postural drainage associated with manual vibration and a mild pressure in the end of expiratory phase
Other intervention name(s): Postural drainage
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will randomized in 2 groups: group CCP (conventional chest physiotherapy techniques) (n=22) , the technique will made during 5 minutes in each side and after that, endotraqueal aspiration will performed.or group PSE (prolonged slow exhalation technique) (n=21), the technique will made during 10 minutes, 2 times a day.At the end, endotraqueal aspiration will perfomed.
During the protocol the parameters will recorder: respiratory rate, heart rate and peripheral oxygen saturation, exhaled tidal volume, number of days under mechanical ventilation and number of fail times in extubation. In 5 diferent moments.
Masking: Single (Participant)
Primary purpose: Treatment