Repercussions of Respiratory Physiotherapy in Preterm Infants Under Mechanical Ventilation (preterm)
Primary Purpose
Preterm Birth
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conventional Physiotherapy
Prolonged slow exhalation technique
Sponsored by

About this trial
This is an interventional treatment trial for Preterm Birth
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Conventional Physiotherapy (PT)
Prolonged slow exhalation technique
Arm Description
Postural drainage + manual vibration
Prolonged exhalation + Conventional PT
Outcomes
Primary Outcome Measures
Tidal volume
Measured by the mechanical ventilator
Secondary Outcome Measures
Respiratory rate
Measured by the mechanical ventilator
Full Information
NCT ID
NCT03159039
First Posted
April 6, 2017
Last Updated
March 13, 2018
Sponsor
Universidade Cidade de Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03159039
Brief Title
Repercussions of Respiratory Physiotherapy in Preterm Infants Under Mechanical Ventilation
Acronym
preterm
Official Title
Study of Clinical Repercussions of Conventional Respiratory Physiotherapy Versus Prolonged Slow Expiration in Preterms Under Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cidade de Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Physiotherapy (PT)
Arm Type
Experimental
Arm Description
Postural drainage + manual vibration
Arm Title
Prolonged slow exhalation technique
Arm Type
Active Comparator
Arm Description
Prolonged exhalation + Conventional PT
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy
Other Intervention Name(s)
Postural drainage
Intervention Type
Other
Intervention Name(s)
Prolonged slow exhalation technique
Intervention Description
Postural drainage associated with manual vibration and a mild pressure in the end of expiratory phase
Primary Outcome Measure Information:
Title
Tidal volume
Description
Measured by the mechanical ventilator
Time Frame
10 minutes twice a day
Secondary Outcome Measure Information:
Title
Respiratory rate
Description
Measured by the mechanical ventilator
Time Frame
10 minutes twice a day
Other Pre-specified Outcome Measures:
Title
Peripheral oxygen saturation
Description
Measured by the oxymeter
Time Frame
10 minutes twice a day
Title
Heart rate
Description
Measured by the oxymeter
Time Frame
10 minutes twice a day
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
gestational age (GA) <35 weeks
Minimum Age & Unit of Time
30 Weeks
Maximum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz Sraiva-Romanholo, PhD
Organizational Affiliation
Universidade Cidade de Sao Paulo
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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 worldwide incidence of preterm birth: a systematic review of maternal mortality and morbidity. Bull World Health Organ. 2010; 88:31-8. Koivisto M, Marttila R, Kurkinen-Raty M, Saarela T, Pokela ML, Jouppila P, et al. Changing incidence and outcome of infants with respiratory distress syndrome in the 1990s: a population-based survey. Acta Paediatr. 2004; 93: 177-184. Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet .2008;371:75-84. Kamath BD, MacGuire ER, McClure EM, Goldenberg RL, Jobe AH. Neonatal Mortality From Respiratory Distress Syndrome: Lessons for Low-Resource Countries. Pediatrics.2011;127:1139-1146. doi: 9.1542/peds.2010-3212 10. Sweet, David G., et al.
Results Reference
result
Learn more about this trial
Repercussions of Respiratory Physiotherapy in Preterm Infants Under Mechanical Ventilation
We'll reach out to this number within 24 hrs