Non-inflatable Supraglottic Airway (NI-SGA) vs. Face Mask (FM) as a Primary Interface Device for Neonatal Resuscitation

Neonatal Resuscitation Clinical Trial

Official title:

Non-inflatable Supraglottic Airway (NI-SGA) vs. Face Mask (FM) as a Primary Interface Device for Neonatal Resuscitation: A Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02629887
• Other study ID #: 5848
• Status: Withdrawn
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: April 15, 2018

Study information

• Verified date: May 2018
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, randomized controlled trial to be performed at one center, of term and late preterm infants requiring resuscitation. Prenatal consent will be obtained. At randomization, babies will be resuscitated following Neonatal Resuscitation Program (NRP) guidelines and ventilated using the T-piece resuscitator with either a Face Mask (FM) or Non-inflating supraglottic airway. Video will be collected during resuscitation as well as written documentation. Primary outcome will be time to spontaneous breathing, length of resuscitation, and need for endotracheal intubation.

Description:

Mothers who are close to delivery of a term or near term infant with estimated fetal weight of 2500gms will be approached for consent to randomize their infant to resuscitation with mask or non-inflatable supraglottic airway (NISGA) if resuscitation is required. Study personnel in delivery will open sequential envelopes with randomized code to indicate which device is to be used if necessary. The resuscitator will be blinded until determination of need of respiratory support. At that time, the appropriate randomized device (face mask or NISGA) will be handed to the resuscitator for use along with T-Piece resuscitator. Video data capture will be used to record type, length and response to resuscitation. This information will be translated to a database prior to destruction of video.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 15, 2018
• Est. primary completion date: April 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Minutes

Eligibility

Inclusion Criteria:

• Newborns > or = 2000gms requiring positive pressure ventilation within the first 2 minutes of life

Exclusion Criteria:

• Newborns with expected fetal weight <2000 grams

• Known congenital malformations

• Multiple gestation (twins and above)

• History of meconium stained fluid

Related Conditions & MeSH terms

• Neonatal Resuscitation

Intervention

Device:
• Non-inflatable supraglottic airway
at delivery if resuscitation is required infant randomized to NI-SGA or face mask as the interface for positive pressure ventilation.
• Face Mask
at delivery - standard airway management per Neonatal Resuscitation Program utilizing face mask.
• T-Piece Resuscitator
T-Piece Resuscitator for providing postivie pressure ventilation via face mask or non-inflatable supraglottic airway

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (25)

Bernhard M, Benger JR. Airway management during cardiopulmonary resuscitation. Curr Opin Crit Care. 2015 Jun;21(3):183-7. doi: 10.1097/MCC.0000000000000201. Review. — View Citation

Deindl P, O'Reilly M, Zoller K, Berger A, Pollak A, Schwindt J, Schmölzer GM. Influence of mask type and mask position on the effectiveness of bag-mask ventilation in a neonatal manikin. Eur J Pediatr. 2014 Jan;173(1):75-9. doi: 10.1007/s00431-013-2122-4. Epub 2013 Aug 11. — View Citation

Ersdal HL, Mduma E, Svensen E, Perlman JM. Early initiation of basic resuscitation interventions including face mask ventilation may reduce birth asphyxia related mortality in low-income countries: a prospective descriptive observational study. Resuscitation. 2012 Jul;83(7):869-73. doi: 10.1016/j.resuscitation.2011.12.011. Epub 2011 Dec 23. — View Citation

Ersdal HL, Singhal N. Resuscitation in resource-limited settings. Semin Fetal Neonatal Med. 2013 Dec;18(6):373-8. doi: 10.1016/j.siny.2013.07.001. Epub 2013 Jul 27. Review. — View Citation

Foglia EE, Owen LS, Thio M, Ratcliffe SJ, Lista G, Te Pas A, Hummler H, Nadkarni V, Ades A, Posencheg M, Keszler M, Davis P, Kirpalani H. Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial. Trials. 2015 Mar 15;16:95. doi: 10.1186/s13063-015-0601-9. — View Citation

Gandini D, Brimacombe JR. Neonatal resuscitation with the laryngeal mask airway in normal and low birth weight infants. Anesth Analg. 1999 Sep;89(3):642-3. — View Citation

Hartung JC, te Pas AB, Fischer H, Schmalisch G, Roehr CC. Leak during manual neonatal ventilation and its effect on the delivered pressures and volumes: an in vitro study. Neonatology. 2012;102(3):190-5. Epub 2012 Jul 10. — View Citation

Kattwinkel J, Perlman JM, Aziz K, Colby C, Fairchild K, Gallagher J, Hazinski MF, Halamek LP, Kumar P, Little G, McGowan JE, Nightengale B, Ramirez MM, Ringer S, Simon WM, Weiner GM, Wyckoff M, Zaichkin J. Part 15: neonatal resuscitation: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S909-19. doi: 10.1161/CIRCULATIONAHA.110.971119. Review. Erratum in: Circulation. 2011 Oct 11;124(15):e406. — View Citation

Kattwinkel J, Perlman JM, Aziz K, Colby C, Fairchild K, Gallagher J, Hazinski MF, Halamek LP, Kumar P, Little G, McGowan JE, Nightengale B, Ramirez MM, Ringer S, Simon WM, Weiner GM, Wyckoff M, Zaichkin J; American Heart Association. Neonatal resuscitation: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Pediatrics. 2010 Nov;126(5):e1400-13. doi: 10.1542/peds.2010-2972E. Epub 2010 Oct 18. Erratum in: Pediatrics. 2011 Jul;128(1):176. — View Citation

Leone TA, Rich W, Finer NN. A survey of delivery room resuscitation practices in the United States. Pediatrics. 2006 Feb;117(2):e164-75. — View Citation

Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015 Jan 31;385(9966):430-40. doi: 10.1016/S0140-6736(14)61698-6. Epub 2014 Sep 30. Erratum in: Lancet. 2015 Jan 31;385(9966):420. Lancet. 2016 Jun 18;387(10037):2506. — View Citation

Nichol G, Huszti E. Design and implementation of resuscitation research: special challenges and potential solutions. Resuscitation. 2007 Jun;73(3):337-46. Epub 2007 Feb 9. Review. — View Citation

O'Donnell CP, Davis PG, Morley CJ. Positive pressure ventilation at neonatal resuscitation: review of equipment and international survey of practice. Acta Paediatr. 2004 May;93(5):583-8. — View Citation

Paterson SJ, Byrne PJ, Molesky MG, Seal RF, Finucane BT. Neonatal resuscitation using the laryngeal mask airway. Anesthesiology. 1994 Jun;80(6):1248-53; discussion 27A. — View Citation

Richmond S, Wyllie J. European Resuscitation Council Guidelines for Resuscitation 2010 Section 7. Resuscitation of babies at birth. Resuscitation. 2010 Oct;81(10):1389-99. doi: 10.1016/j.resuscitation.2010.08.018. — View Citation

Schilleman K, van der Pot CJ, Hooper SB, Lopriore E, Walther FJ, te Pas AB. Evaluating manual inflations and breathing during mask ventilation in preterm infants at birth. J Pediatr. 2013 Mar;162(3):457-63. doi: 10.1016/j.jpeds.2012.09.036. Epub 2012 Oct 25. — View Citation

Schmölzer GM, Agarwal M, Kamlin CO, Davis PG. Supraglottic airway devices during neonatal resuscitation: an historical perspective, systematic review and meta-analysis of available clinical trials. Resuscitation. 2013 Jun;84(6):722-30. doi: 10.1016/j.resuscitation.2012.11.002. Epub 2012 Nov 9. Review. — View Citation

Schmölzer GM, Kamlin OC, O'Donnell CP, Dawson JA, Morley CJ, Davis PG. Assessment of tidal volume and gas leak during mask ventilation of preterm infants in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2010 Nov;95(6):F393-7. doi: 10.1136/adc.2009.174003. Epub 2010 Jun 14. — View Citation

Schreiner MS, Feltman D, Wiswell T, Wootton S, Arnold C, Tyson J, Lantos JD. When is waiver of consent appropriate in a neonatal clinical trial? Pediatrics. 2014 Nov;134(5):1006-12. doi: 10.1542/peds.2014-0207. Epub 2014 Oct 6. Review. — View Citation

Szyld E, Aguilar A, Musante GA, Vain N, Prudent L, Fabres J, Carlo WA; Delivery Room Ventilation Devices Trial Group. Comparison of devices for newborn ventilation in the delivery room. J Pediatr. 2014 Aug;165(2):234-239.e3. doi: 10.1016/j.jpeds.2014.02.035. Epub 2014 Mar 29. — View Citation

Trevisanuto D, Cavallin F, Nguyen LN, Nguyen TV, Tran LD, Tran CD, Doglioni N, Micaglio M, Moccia L. Supreme Laryngeal Mask Airway versus Face Mask during Neonatal Resuscitation: A Randomized Controlled Trial. J Pediatr. 2015 Aug;167(2):286-91.e1. doi: 10.1016/j.jpeds.2015.04.051. Epub 2015 May 21. — View Citation

Wyckoff MH, Perlman JM, Laptook AR. Use of volume expansion during delivery room resuscitation in near-term and term infants. Pediatrics. 2005 Apr;115(4):950-5. — View Citation

Wyckoff MH, Perlman JM. Effective ventilation and temperature control are vital to outborn resuscitation. Prehosp Emerg Care. 2004 Apr-Jun;8(2):191-5. — View Citation

Zanardo V, Weiner G, Micaglio M, Doglioni N, Buzzacchero R, Trevisanuto D. Delivery room resuscitation of near-term infants: role of the laryngeal mask airway. Resuscitation. 2010 Mar;81(3):327-30. doi: 10.1016/j.resuscitation.2009.11.005. Epub 2009 Dec 22. — View Citation

Zhu XY, Lin BC, Zhang QS, Ye HM, Yu RJ. A prospective evaluation of the efficacy of the laryngeal mask airway during neonatal resuscitation. Resuscitation. 2011 Nov;82(11):1405-9. doi: 10.1016/j.resuscitation.2011.06.010. Epub 2011 Jul 16. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Spontaneous Breathing	Record of time from beginning of resuscitation to time of spontaneous breathing	30 minutes
Primary	Duration of Positive Pressure Ventilation	Total time of positive pressure ventilation required to adequate spontaneous breathing.	30 minutes
Primary	Need for subsequent endotracheal intubation	Failure of non-invasive resuscitative efforts by face mask or NI-SGA requiring intubation per NRP guideline.	30 minutes
Secondary	Time needed for NI-SGA placement	Time needed adequate placement of non-inflatable supraglottic airway	1 minute
Secondary	Need for drugs in resuscitation	Drug administration as part of the standard neonatal resuscitation per NRP	30 minutes
Secondary	Use of Chest Compressions	Need for chest compressions as part of neonatal resuscitation per NRP guidelines	30 minutes
Secondary	Use of oxygen	Amount and duration of oxygen use in resuscitation	30 minutes
Secondary	Rate of complications associated with resuscitation	Presence of complications including bleeding, abdominal distension, laryngeal stridor	30 minutes
Secondary	Heart rate 2 minutes after initiation of resuscitation	Heart rate assessed at 2 minutes	2 minutes
Secondary	Maximum inspiratory pressure	Record of highest peak inspiratory pressure used in resuscitation	30 minutes