Evaluating the feasibility and safety of video laryngoscopy for routine nasotracheal intubation in neonates - a randomized controlled pilot trial

Evaluating the feasibility and safety of video laryngoscopy for routine nasotracheal intubation in neonates - a randomized controlled pilot trial - Violin

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00020792

Enrollment

Registered

2020-02-07

Start date

2020-02-21

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

P28.5 P22.0

Interventions

Group 1: Nasotracheal intubation using video laryngoscopy (Acutronic Infantview®) Group 2: Nasotracheal intubation using direct laryngoscopy (traditional laryngoscope)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Indication for endotracheal intubation, Age < 44 weeks postmenstrual age

Exclusion criteria

Exclusion criteria: Declined participation, Equipment failure, Personnel not confident, Intubation outside neonatal intensive care unit (NICU) or delivery suite (DR)

Design outcomes

Primary

Measure	Time frame
First-pass success rate (passing the endotracheal tube through the vocal chords at first attempt)	—

Secondary

Measure	Time frame
(1) Adverse events (death, cardiopulmonary resuscitation, application of adrenaline, airway injury/bleeding, chest wall rigidity, vomiting, esophageal intubation with or without desaturation < 80%, treatment of arterial hypotension, treatment of pain/discomfort, intraventricular hemorrhage, pneumothorax, main stem intubation, difficult mask ventilation, additional equipment required, change to emergency intubation) (2) Desaturations (any < 80% and any < 60%), bradycardias (any < 100/min and any < 60/min) (3) COMFORTneo score (before and during first laryngoscopy in each case via blinded assessments of video recordings) (4) Attempts until successful intubation (5) Endotracheal tube position on first X-ray (main stem, < 1 cm from carina, mid-trachea, above level of clavicles) (6) Cormack-Lehane classification system (according to O’Shea et al.18) (7) Frequency of cross-over and questionnaire concerning staff satisfaction with overall intubation conditions (8) Questionnaire concerning staff satisfaction with trial implementation (to be completed by the entire staff one time before and after the trial) (9) Questionnaire concerning parental perception of trial participation and consent procedure	—

Measure

Time frame

(1) Adverse events (death, cardiopulmonary resuscitation, application of adrenaline, airway injury/bleeding, chest wall rigidity, vomiting, esophageal intubation with or without desaturation < 80%, treatment of arterial hypotension, treatment of pain/discomfort, intraventricular hemorrhage, pneumothorax, main stem intubation, difficult mask ventilation, additional equipment required, change to emergency intubation) (2) Desaturations (any < 80% and any < 60%), bradycardias (any < 100/min and any < 60/min) (3) COMFORTneo score (before and during first laryngoscopy in each case via blinded assessments of video recordings) (4) Attempts until successful intubation (5) Endotracheal tube position on first X-ray (main stem, < 1 cm from carina, mid-trachea, above level of clavicles) (6) Cormack-Lehane classification system (according to O’Shea et al.18) (7) Frequency of cross-over and questionnaire concerning staff satisfaction with overall intubation conditions (8) Questionnaire concerning staff satisfaction with trial implementation (to be completed by the entire staff one time before and after the trial) (9) Questionnaire concerning parental perception of trial participation and consent procedure

—

Countries

Germany

Contacts

Public ContactAndré Kidszun

Universitätsmedizin Mainz, Zentrum für Kinder- und Jugendmedizin

andre.kidszun@unimedizin-mainz.de06131 17 5892

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026