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

Sponsor
University of Oklahoma (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02629887
Collaborator
(none)
0
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Non-inflatable supraglottic airway
  • Device: Face Mask
  • Device: T-Piece Resuscitator
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Non-inflatable Supraglottic Airway (NI-SGA) vs. Face Mask (FM) as a Primary Interface Device for Neonatal Resuscitation: A Pilot Study
Anticipated Study Start Date :
Apr 15, 2018
Anticipated Primary Completion Date :
Apr 15, 2018
Anticipated Study Completion Date :
Apr 15, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Face Mask

Standard Face Mask with T piece resuscitator for neonatal resuscitation. Face mask placement per Neonatal Resuscitation Program resuscitation guideline.

Device: Face Mask
at delivery - standard airway management per Neonatal Resuscitation Program utilizing face mask.

Device: T-Piece Resuscitator
T-Piece Resuscitator for providing postivie pressure ventilation via face mask or non-inflatable supraglottic airway
Active Comparator: Non-inflatable supraglottic airway

Use of non-inflating supraglottic airway with T-piece resuscitator instead of Standard Face Mask with T piece resuscitator for neonatal resuscitation, replacing standard of care face mask in Neonatal Resuscitation Program guideline.

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.

Device: T-Piece Resuscitator
T-Piece Resuscitator for providing postivie pressure ventilation via face mask or non-inflatable supraglottic airway

Outcome Measures

Primary Outcome Measures

  1. Time to Spontaneous Breathing [30 minutes]

    Record of time from beginning of resuscitation to time of spontaneous breathing

  2. Duration of Positive Pressure Ventilation [30 minutes]

    Total time of positive pressure ventilation required to adequate spontaneous breathing.

  3. Need for subsequent endotracheal intubation [30 minutes]

    Failure of non-invasive resuscitative efforts by face mask or NI-SGA requiring intubation per NRP guideline.

Secondary Outcome Measures

  1. Time needed for NI-SGA placement [1 minute]

    Time needed adequate placement of non-inflatable supraglottic airway

  2. Need for drugs in resuscitation [30 minutes]

    Drug administration as part of the standard neonatal resuscitation per NRP

  3. Use of Chest Compressions [30 minutes]

    Need for chest compressions as part of neonatal resuscitation per NRP guidelines

  4. Use of oxygen [30 minutes]

    Amount and duration of oxygen use in resuscitation

  5. Rate of complications associated with resuscitation [30 minutes]

    Presence of complications including bleeding, abdominal distension, laryngeal stridor

  6. Heart rate 2 minutes after initiation of resuscitation [2 minutes]

    Heart rate assessed at 2 minutes

  7. Maximum inspiratory pressure [30 minutes]

    Record of highest peak inspiratory pressure used in resuscitation

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 30 Minutes
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73117

Sponsors and Collaborators

  • University of Oklahoma

Investigators

  • Principal Investigator: Arlen Foulks, DO, University of Oklahoma

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT02629887
Other Study ID Numbers:
  • 5848
First Posted:
Dec 14, 2015
Last Update Posted:
May 9, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by University of Oklahoma
supraglottic airway
neonatal resuscitation
ventilation
term infant

Study Results

No Results Posted as of May 9, 2018