Integrated Prediction of Extubation Outcome by the Spontaneous Breathing Trial in Newborn Infants

NCT03956511 | Completed DMC

• 1 other identifier: 193377
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Prolonged mechanical ventilation (MV) is associated with significant adverse effects in newborn infants and clinicians aim at its minimum possible duration. Failed extubation and need for reintubation is common and further prolongs the duration of MV. Hence, accurate prediction of readiness for extubation would incur a considerable reduction in respiratory morbidity. The Spontaneous breathing Trial (SBT) involves placing the infant on endotracheal continuous positive airway pressure for five minutes with continuous monitoring of heart rate and oxygen saturation levels. The infant would pass the test if there is no hypoxia or bradycardia during the trial. A successful SBT might predict successful extubation. The respiratory muscles play a crucial role in successful extubation. One simple way to quantify respiratory muscle function is the rate of relaxation of the inspiratory muscles that can be depicted by the rate of the decline of the airway pressure signal following a spontaneous breath. The hypothesis of the investigator is that respiratory muscle function assessment using the rate of relaxation of the inspiratory muscles during a SBT can accurately predict extubation outcomes either independently or in conjunction with the outcome of the SBT and the variability of the respiratory parameters during the SBT. This could increase the predicting accuracy of extubation outcomes and thus reduce re-intubation associated respiratory morbidity.

Conditions

Infant, Newborn, Diseases; Airway Morbidity

Outcome Measures

Primary Outcomes (2)

• Reintubation within 72 hours from extubation

  Reintubation will be assessed by reviewing infant's ventilation state

  Through study completion, an average one year

• Reintubation within 72 hours from extubation

  Reintubation will be assessed by reviewing infant's clinical records

  Through study completion, an average one year

Secondary Outcomes (2)

• Comparison of the rate of relaxation of respiratory muscles between premature infants that fail extubation and premature infants that successfully wean off mechanical ventilation.

  Through study completion, an average one year

• Comparison of the rate of relaxation of respiratory muscles between premature infants and term infants.

  Through study completion, an average one year

Interventions

Spontaneous Breathing Trial OTHER

It involves placing an infant from invasive mechanical pressure limited time cycled ventilation ventilation to endotracheal continuous positive end-expiratory pressure (ET-CPAP) for a period of 5 minutes during which saturation and heart rate are closely monitored. The infant would pass the test if there is no hypoxia or bradycardia during the test. If the infant has either bradycardia for more than 15 seconds and/or a fall in SpO2 below 85% despite a 15% increase in FIO2, the study will be stopped and ventilation will be restarted.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All infants with a planned extubation during the study period.

You may qualify if:

• All infants with a planned extubation.

You may not qualify if:

• Infants with known genetic or chromosomal abnormalities.
• Infants with congenital anomalies other than Congenital Diaphragmatic Hernia or Anterior Wall Defect and
• Infants with focal acute lung pathology such as atelectasis or pneumothorax will be excluded from the study.

Sponsors & Collaborators

• Ourania Kaltsogianni: lead
• King's College London: collaborator

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Related Publications (12)

• Kamlin CO, Davis PG, Morley CJ. Predicting successful extubation of very low birthweight infants. Arch Dis Child Fetal Neonatal Ed. 2006 May;91(3):F180-3. doi: 10.1136/adc.2005.081083. Epub 2006 Jan 12.

  PMID: 16410255 BACKGROUND

• Stefanescu BM, Murphy WP, Hansell BJ, Fuloria M, Morgan TM, Aschner JL. A randomized, controlled trial comparing two different continuous positive airway pressure systems for the successful extubation of extremely low birth weight infants. Pediatrics. 2003 Nov;112(5):1031-8. doi: 10.1542/peds.112.5.1031.

  PMID: 14595042 BACKGROUND

• Currie A, Patel DS, Rafferty GF, Greenough A. Prediction of extubation outcome in infants using the tension time index. Arch Dis Child Fetal Neonatal Ed. 2011 Jul;96(4):F265-9. doi: 10.1136/adc.2010.191015. Epub 2010 Nov 20.

  PMID: 21097837 BACKGROUND

• Dimitriou G, Fouzas S, Vervenioti A, Tzifas S, Mantagos S. Prediction of extubation outcome in preterm infants by composite extubation indices. Pediatr Crit Care Med. 2011 Nov;12(6):e242-9. doi: 10.1097/PCC.0b013e3181fe3431.

  PMID: 21037500 BACKGROUND

• Kavvadia V, Greenough A, Dimitriou G. Prediction of extubation failure in preterm neonates. Eur J Pediatr. 2000 Apr;159(4):227-31. doi: 10.1007/s004310050059.

  PMID: 10789923 BACKGROUND

• Mikhno A, Ennett CM. Prediction of extubation failure for neonates with respiratory distress syndrome using the MIMIC-II clinical database. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:5094-7. doi: 10.1109/EMBC.2012.6347139.

  PMID: 23367074 BACKGROUND

• Kaczmarek J, Kamlin CO, Morley CJ, Davis PG, Sant'anna GM. Variability of respiratory parameters and extubation readiness in ventilated neonates. Arch Dis Child Fetal Neonatal Ed. 2013 Jan;98(1):F70-3. doi: 10.1136/fetalneonatal-2011-301340. Epub 2012 May 3.

  PMID: 22556206 BACKGROUND

• Kyroussis D, Mills G, Hamnegard CH, Wragg S, Road J, Green M, Moxham J. Inspiratory muscle relaxation rate assessed from sniff nasal pressure. Thorax. 1994 Nov;49(11):1127-33. doi: 10.1136/thx.49.11.1127.

  PMID: 7831629 BACKGROUND

• American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.

  PMID: 12186831 BACKGROUND

• Dassios T, Kaditis A, Katelari A, Chrousos G, Doudounakis S, Dimitriou G. Time constant of inspiratory muscle relaxation in cystic fibrosis. Pediatr Res. 2015 Apr;77(4):541-5. doi: 10.1038/pr.2015.2. Epub 2015 Feb 2.

  PMID: 25642662 BACKGROUND

• Kyroussis D, Johnson LC, Hamnegard CH, Polkey MI, Moxham J. Inspiratory muscle maximum relaxation rate measured from submaximal sniff nasal pressure in patients with severe COPD. Thorax. 2002 Mar;57(3):254-7. doi: 10.1136/thorax.57.3.254.

  PMID: 11867831 BACKGROUND

• Kassim Z, Moxham J, Davenport M, Nicolaides K, Greenough A, Rafferty GF. Respiratory muscle strength in healthy infants and those with surgically correctable anomalies. Pediatr Pulmonol. 2015 Jan;50(1):71-8. doi: 10.1002/ppul.23007. Epub 2014 Feb 20.

  PMID: 24574153 BACKGROUND

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Theodore Dassios, Consultant

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Ourania Kaltsogianni, MSc Advanced Paediatrics

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: May 20, 2019
• Study Start: February 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)