Repercussions of Respiratory Physiotherapy in Preterm Infants Under Mechanical Ventilation

Preterm Birth Clinical Trial

— preterm  

Official title:

Study of Clinical Repercussions of Conventional Respiratory Physiotherapy Versus Prolonged Slow Expiration in Preterms Under Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159039
• Other study ID #: preterm physiotherapy
• Status: Completed
• Phase: N/A
• First received: April 6, 2017
• Last updated: March 13, 2018
• Start date: January 2015
• Est. completion date: October 2017

Study information

• Verified date: March 2018
• Source: Universidade Cidade de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Weeks to 34 Weeks

Eligibility

Inclusion Criteria:

• Preterms born at gestational age <35 weeks under mechanical ventilation

Exclusion Criteria:

• congenital malformation graves;

• genetic syndromes,

• pulmonary hypertension,

• peri-intraventricular haemorrhage and coagulopathies.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Other:
• Conventional Physiotherapy

• Prolonged slow exhalation technique
Postural drainage associated with manual vibration and a mild pressure in the end of expiratory phase

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo

References & Publications (1)

Blencowe H, Cousens S, Chou D, et al. Born Too Soon: The global epidemiology of 15 million preterm births. Reproductive Health. 2013;10(Suppl 1):S2. doi:10.1186/1742-4755-10-S1-S2. Beck , Wojdyla LS, Betran AP, Merialdi M, Requejo JH, Rubens C, et al. The

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Peripheral oxygen saturation	Measured by the oxymeter	10 minutes twice a day
Other	Heart rate	Measured by the oxymeter	10 minutes twice a day
Primary	Tidal volume	Measured by the mechanical ventilator	10 minutes twice a day
Secondary	Respiratory rate	Measured by the mechanical ventilator	10 minutes twice a day