Role of lung ultrasound in predicting the right time when a newborn on ventilator is ready to breathe on their own

Not yet recruiting

Conditions: Respiratory failure of newborn,

Registration Number: CTRI/2025/03/081596

Lead Sponsor: Himalayan Institute of Medical Sciences

Brief Summary: Both inborn and outborn neonates fulfilling inclusion criteria will ne enrolled. Initially in pre- initiation training, a senior resident will be trained by consultant neonatologist for 1 month. To decrease inter observer variability when k > 0.8, study will be initiated. Subjects will be enrolled 2 hours before extubation. Demographics and perinatal details will be collected. Babies admitted to NICU will be followed prospectively and details of management will be recorded like whether received surfactant or not indication of ventilation, mode and duration of ventilation, settings of ventilator, maximum ventilation index during ventilation, maximum respiratory severity score (RSS) during ventilation. Lung USG score will be done within 2 hours before extubation. Baby can be extubated if FiO2 requirement < 40 %, MAP < 8- 10cm H2O, Respiratory rate of the ventilator < 30/min, presence of spontaneous breathing, haemodynamically stable without or with 1 ionotrope, last haemoglobin>10 mg/dl , no metabolic acidosis (pH>7.2) with PaCO2- < 55mmHg, PaO2>40 mmHg in arterial blood gas (ABG) done 2 hours before extubation or based on clinical judgement of consultant neonatologist. Post extubation neonate will be shifted to non invasive mode of ventilation (NIV). Lung ultrasound score of those who failed the first extubation attempt and those who were successful will be compared to develop final cut off score for extubation success.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 62

Inclusion Criteria

All consecutive neonates on conventional ventilation for at least 24 hours.

Exclusion Criteria

Previous extubation failures Accidental extubation Life threatening congenital malformations Upper airway malformations Surgical cases(Tracheo-esophageal fistula, congenital diaphragmatic hernia, intestinal atresia, necrotising enterocolitis) requiring intubation Neonates with critical congenital heart disease Chest deformities.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate predictive ability of lung ultrasound for extubation success.	till 3 days post extubation
Word outcome refers to no need of re-intubation within 3 days after extubation(successful extubation)	till 3 days post extubation

Secondary Outcome Measures

Name	Time	Method
1.To develop cut off lung ultrasound score with highest area under curve (AUC)for extubation success.	2.To compare predictive ability of lung ultrasound score on screening 6 versus 12 areas for extubation success.

Trial Locations

Locations (1): Himalayan Institute of Medical Sciences
🇮🇳
Dehradun, UTTARANCHAL, India
Himalayan Institute of Medical Sciences
🇮🇳Dehradun, UTTARANCHAL, India
Dr Chinmay Chetan
Principal investigator
9871770076
mechinmay@gmail.com