The Impact of Lung Recruitment Maneuver in 24-32 Weekers, and the Incidence of Bronchopulmonary Dysplasia

Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K)

Status: Unknown

Conditions: Bronchopulmonary Dysplasia

Treatments: Device: lung recruitment maneuver (LRM) with DrageerVN500

Study type: Interventional

Funder types: Other

Identifiers

NCT04555889

Med. Fac. of Univ. Indonesia

Details and patient eligibility

About

hypothesis :

1. The incident of dysplasia bronchopulmonary and/or death in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
2. The serum levels of surfactant protein-D in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
3. The serum concentration of CD-31+ and CD-42b- in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
4. The right and left cardiac output in 24-32 weekers babies on assist-control volume guarantee mode are more higher in lung recruitment maneuver (LRM) group, than group that did not get LRM
5. The incident Patent Ductus Arteriosus in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
6. The difference tc-pCO2 - PaCO2 , tcO2 index , and strong ion difference (SID) in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.

Full description

description of the protocol :

1. All Babies that meet inclusion criteria would immediately given surfactan. Babies will do echocardiography, blood gas analize, blood sample, transcutaneous monitor. After that babies will be randomized, the intervention group will get standart protocol + lung recruitment maneuver (LRM) and another group get standart protocol only.
2. The lung recruitment maneuver (LRM) will be done by increasing of PEEP 0,2 cm H2O every 3 minutes, until reach the opening pressure. After that PEEP decrease gradually until get the closing pressure. Than the investigators will back to the opening pressure for 3 minutes, and the final PEEP will be put back 0,2 above closing pressure.
3. After 3rd days (72 hours) babies, the investigators will exime serum levels of surfactan protein-D, CD-31+ and CD-42b- , blood gas , tc-pCO2 - PaCO2 , tcO2 index.
4. After that babies will observe within 28 days to detect Bronchopulmonary dysplasia

Enrollment: 110 estimated patients

Sex: All

Ages: Under 48 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 24-32 weeks preterm babies.
• Babies on assist-control volume guarantee ventilation with FiO2 > 30% to reach oxygen saturations within 90-95%.
• Age less than 48 hours.
• Born in Cipto Mangunkusumo Hospital and Bunda Menteng Hospital.
• Parents/guardians agreed to participate in this study with sign informed consent.

Exclusion criteria

• Weight birth <750 grams.
• APGAR score at 10 minutes are <5.
• Born with congenital heart disease except patent ductus arteriosus or presistence foramen ovale.
• Born with congenital disorder that need surgery intervention (for example :

diaphragmatic hernia, atresia ani, esophageal atresia, duodenal atresia.

• Born with congenital disorder that worsening of the respiratory distress (for example

  • hydrops fetalis, phrenic nerve paralysis, abnormality of chest wall, abnormality of air way (for example : Choanal atresia, Laryngeal stenosis, cleft palate.

• Born inborn error metabolism disease.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

lung recruitment maneuver (LRM) group

Experimental group

Description:

The lung recruitment maneuver (LRM) will be done by increasing of PEEP 0,2 cm H2O every 3 minutes, until reach the opening pressure. After that PEEP decrease gradually until get the closing pressure. Than the investigators will back to the opening pressure for 3 minutes, and the final PEEP will be put backo 0,2 above closing pressure.

Treatment:

Device: lung recruitment maneuver (LRM) with DrageerVN500

without lung recruitment maneuver (LRM) group

No Intervention group

Description:

Another group get standart protocol only.