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Publication

  • Title: Video versus Direct Laryngoscopy for Urgent Intubation of Newborn Infants
  • Acronym: VODE
  • Year: 2024
  • Journal published in: New England Journal of Medicine
  • Citation: Geraghty LE, Dunne EA, Ní Chathasaigh CM, Vellinga A, Adams NC, O’Currain EM, et al. Video versus Direct Laryngoscopy for Urgent Intubation of Newborn Infants. N Engl J Med. 2024;390(20):1885-94.

Context & Rationale

  • Background
    • Urgent neonatal endotracheal intubation in delivery rooms and NICUs is technically challenging, commonly undertaken by trainees, and often requires multiple attempts.
    • Repeated laryngoscopy attempts in newborn infants are associated with hypoxaemia, bradycardia, airway trauma, and escalation to chest compressions and epinephrine.
    • Video laryngoscopy provides a shared external view of the glottis that may improve glottic visualisation, facilitate supervision and coaching, and increase first-pass success.
    • Pre-trial neonatal evidence was limited by small trials (often teaching-focussed), heterogeneous devices and settings, and uncertainty regarding clinical effectiveness and physiologic safety during urgent real-world intubations.
  • Research Question/Hypothesis
    • In newborn infants requiring urgent oral endotracheal intubation, does video laryngoscopy (vs direct laryngoscopy) increase successful intubation on the first attempt?
    • Does any increase in first-pass success occur without an excess of physiologic deterioration (desaturation, bradycardia) or procedural complications?
  • Why This Matters
    • First-pass success is a clinically meaningful process measure in neonatal airway management, plausibly linked to short-term morbidity through fewer hypoxic/bradycardic episodes and less traumatic instrumentation.
    • Routine adoption of video laryngoscopy has resource, training, and workflow implications; robust RCT evidence is required to justify broad implementation in high-stakes neonatal care environments.

Design & Methods

  • Research Question: Among newborn infants undergoing urgent oral endotracheal intubation, does video laryngoscopy increase successful intubation on the first attempt compared with direct laryngoscopy?
  • Study Type: Pragmatic, single-centre, parallel-group, superiority randomised trial; 1:1 allocation; stratified by gestational age (<32 weeks vs ≥32 weeks) with blocks of four; open-label; no interim analyses reported.
  • Population:
    • Setting: delivery rooms and neonatal intensive care unit in a tertiary maternity hospital (Dublin, Ireland).
    • Inclusion: newborn infants of any gestational age requiring urgent oral endotracheal intubation in the delivery room or NICU; each infant participated once.
    • Key exclusions: known or suspected upper airway anomaly (e.g., cleft palate, craniofacial anomaly, intracranial tumour abutting the airway); parental/guardian refusal; clinician device preference precluding randomisation.
    • Consent: prospective informed consent when feasible; otherwise deferred consent after the procedure.
  • Intervention:
    • First attempt with C-MAC video laryngoscope using Miller blade (size 0 for <1500 g; size 1 for ≥1500 g); airway visualised on an external monitor.
    • Operators and supervisors could view the monitor; real-time supervision/coaching permitted.
    • Subsequent attempts and adjuncts (stylet, premedication, etc.) at clinician discretion.
  • Comparison:
    • First attempt with conventional direct laryngoscope (Heine Optotechnik) using straight blade (size 00 for <1000 g; size 0 for 1000–3000 g; size 1 for >3000 g).
    • After the initial attempt, device choice for further attempts was not restricted (including crossover to video laryngoscopy).
  • Blinding: Unblinded (device visible to operator and team); blinding not feasible; primary outcome confirmation used objective exhaled CO2 detection.
  • Statistics: A total of 214 intubations were planned to detect an absolute increase in first-attempt success from 40% to 60% with 80% power at a two-sided 5% significance level (194 required, inflated for attrition); primary analysis by chi-square test; intention-to-treat principle described for included infants; secondary outcomes reported descriptively with 95% CIs and without hypothesis testing.
  • Follow-Up Period: Immediate peri-intubation period (success, physiologic nadirs, procedural events) and post-procedure chest radiograph for endotracheal tube tip position; longer-term clinical outcomes were not reported.

Key Results

This trial was not stopped early. 226 newborn infants were randomised; 214 were included in the primary analysis.

Outcome Video laryngoscopy Direct laryngoscopy Effect p value / 95% CI Notes
Successful intubation on first attempt 79/107 (74%; 95% CI 66 to 82) 48/107 (45%; 95% CI 35 to 54) Not reported P<0.001 Primary outcome; success confirmed by exhaled CO2 detection.
Median number of attempts to achieve successful intubation 1 (95% CI 1 to 1) 2 (95% CI 1 to 2) Not reported Not reported Assessed in 107 vs 107 infants.
Lowest oxygen saturation during laryngoscopy (median) 74% (95% CI 65 to 78) 68% (95% CI 62 to 74) Not reported Not reported Assessed in 98 vs 100 infants.
Oxygen saturation <90% during laryngoscopy 79/107 (74%; 95% CI 65 to 82) 96/107 (90%; 95% CI 84 to 96) Not reported Not reported Post-hoc outcome (added after data collection completed).
Lowest heart rate during laryngoscopy (median) 153 bpm (95% CI 148 to 158) 148 bpm (95% CI 140 to 156) Not reported Not reported Assessed in 98 vs 100 infants.
Heart rate <60 bpm during laryngoscopy 6/107 (6%; 95% CI 1 to 11) 9/107 (8%; 95% CI 3 to 13) Not reported Not reported Physiologic safety outcome.
Chest compressions during the procedure 6/107 (6%; 95% CI 2 to 11) 5/107 (5%; 95% CI 1 to 9) Not reported Not reported Serious procedural deterioration.
Epinephrine during the procedure 3/107 (3%; 95% CI 0 to 6) 1/107 (1%; 95% CI 0 to 3) Not reported Not reported Low-frequency serious event.
Oral trauma 0/107 (0%; 95% CI 0 to 3) 1/107 (1%; 95% CI 0 to 4) Not reported Not reported Assessed as procedural complication.
Crossover to alternative device 3/99 (3%; 95% CI 0 to 6) 29/99 (29%; 95% CI 20 to 38) Not reported Not reported Assessed in 99 vs 99 infants.
Endotracheal tube tip in correct position on chest radiograph 56/105 (53%; 95% CI 44 to 63) 52/105 (50%; 95% CI 40 to 59) Not reported Not reported Correct position defined as between T1 and T2; assessed in 105 vs 105 infants.
Intubation successfully completed with assigned device 103/107 (96.3%) 74/107 (69.2%) Not reported Not reported Post-hoc outcome (supplement).
Total laryngoscopy time to successful intubation (median) 66 sec (95% CI 57 to 76) 96 sec (95% CI 85 to 111) Not reported Not reported Post-hoc outcome (supplement).
  • Interpretation highlights
    • First-attempt success was higher with video laryngoscopy (74%) than with direct laryngoscopy (45%) (P<0.001).
    • Procedural difficulty proxies favoured video laryngoscopy (median 1 attempt to success and 3% crossover) vs direct laryngoscopy (median 2 attempts and 29% crossover).
    • Physiologic instability remained common: median lowest oxygen saturation was 74% (video) vs 68% (direct), while chest compressions (6% vs 5%) and epinephrine use (3% vs 1%) were uncommon and similar.
  • Subgroups (successful first attempt; post-hoc; no CIs reported)
    • Neonatologists: 6/8 (75.0%) vs 1/3 (33.3%).
    • Neonatology trainees: 25/31 (80.6%) vs 20/36 (55.6%).
    • Paediatric trainees: 38/54 (70.4%) vs 25/61 (41.0%).

Internal Validity

  • Randomisation and allocation:
    • Allocation by sealed opaque envelopes; stratified by gestational age (<32 vs ≥32 weeks) in blocks of four.
    • Randomisation occurred immediately before the first attempt, limiting post-allocation co-intervention planning but requiring envelope access in emergent settings.
  • Dropout/exclusions:
    • Randomised: 226 infants (115 video; 111 direct).
    • Excluded post-randomisation: 12/226 (5.3%) — deferred consent not obtained (7 video; 4 direct) and clinical improvement/no intubation (1 video).
    • Analysed: 214 infants (107 per group).
  • Performance and detection bias:
    • Unblinded clinicians; device visibility could influence behaviour (including supervision and coaching intensity).
    • Primary outcome was objectively confirmed by exhaled CO2 detection, reducing susceptibility to subjective outcome assessment.
    • Secondary outcomes included objective physiologic measures (oxygen saturation, heart rate) but with incomplete capture (e.g., lowest oxygen saturation assessed in 98 vs 100 infants).
  • Protocol adherence and separation of the variable of interest:
    • Protocol violation: 1 infant allocated to video laryngoscopy had direct laryngoscopy on the first attempt because the video laryngoscope was not available.
    • Median attempts to success: 1 (video) vs 2 (direct).
    • Crossover to an alternative device: 3/99 (3%) in video vs 29/99 (29%) in direct.
    • Intubation completed with assigned device (post-hoc): 103/107 (96.3%) in video vs 74/107 (69.2%) in direct.
  • Baseline characteristics and illness severity:
    • Gestational age (median): 29.6 weeks (video) vs 28.4 weeks (direct); birth weight (median): 1235 g vs 1040 g.
    • FiO2 at randomisation (mean ± SD): 0.66 ± 0.29 vs 0.65 ± 0.28.
    • Premedication: 67/107 (63%) vs 80/107 (75%); stylet use: 104/107 (97%) vs 104/107 (97%).
  • Heterogeneity and timing:
    • Mix of delivery room and NICU intubations (delivery room: 36% vs 23%).
    • Age at randomisation (median): 1:51 vs 3:41 (hh:mm).
    • Broad gestational age range, with stratification by <32 vs ≥32 weeks to mitigate imbalance.
  • Outcome assessment and statistical rigour:
    • Primary analysis prespecified and adequately powered; no interim analyses reported.
    • Secondary outcomes were presented descriptively with 95% CIs and not used for hypothesis testing; several outcomes were post-hoc.

Conclusion on Internal Validity: Overall, internal validity appears moderate: randomisation and protocol delivery produced clear separation for the primary intervention (and an objective primary endpoint), but post-randomisation consent-related exclusions, lack of blinding, and substantial crossover in the direct laryngoscopy group could influence the magnitude of the observed benefit.

External Validity

  • Population representativeness:
    • Single tertiary maternity hospital; results are most directly applicable to similar delivery room and NICU settings with comparable staffing and training models.
    • High proportion of preterm infants (≈70% <32 weeks), reflecting many tertiary NICU populations but potentially differing from lower-acuity units.
    • First attempts were commonly performed by trainees (paediatric trainees: 54/107 vs 61/107; neonatology trainees: 31/107 vs 36/107), aligning with real-world practice in many centres.
  • Applicability:
    • Device-specific (C-MAC video laryngoscope; Heine direct laryngoscope); effect size may differ with other video systems, blade geometries, or screen configurations.
    • Peri-intubation practice (including premedication strategy and oxygen delivery during attempts) may vary across units, affecting physiologic event rates and potential benefit.
    • Pragmatic co-interventions improve real-world relevance but may limit transportability to settings with more standardised airway bundles or different supervision structures.

Conclusion on External Validity: External validity is moderate: the findings likely generalise to comparable delivery room/NICU environments with trainee operators and access to video laryngoscopy, but the observed effect size and safety profile may differ with alternative devices, oxygenation strategies, and operator experience.

Strengths & Limitations

  • Strengths:
    • Randomised, stratified trial addressing a high-stakes neonatal procedure in real-world delivery room and NICU settings.
    • Clinically relevant, objective primary endpoint (first-attempt success confirmed by exhaled CO2 detection).
    • High procedural detail with quantification of physiologic deterioration and resuscitation interventions.
    • Pragmatic approach (adjuncts and escalation at clinician discretion) enhances clinical relevance.
  • Limitations:
    • Single-centre and unblinded; performance effects (including supervision/coaching enabled by a shared screen) could contribute to the observed benefit.
    • Post-randomisation exclusions due to deferred consent not obtained (and one infant not intubated) limit a strict intention-to-treat analysis among all randomised infants.
    • Secondary outcomes were largely descriptive (no hypothesis testing) and some were post-hoc, increasing risk of over-interpretation.
    • Meaningful downstream clinical outcomes (e.g., longer-term respiratory or neurological morbidity) were not reported.

Interpretation & Why It Matters

  • Clinical effectiveness
    Video laryngoscopy substantially increased first-pass success for urgent neonatal intubation (74% vs 45%), a process outcome strongly linked to procedural safety and escalation risk.
  • Physiological safety
    Severe desaturation and bradycardia remained common in both groups, but major resuscitation interventions were uncommon and similar (chest compressions 6% vs 5%; epinephrine 3% vs 1%).
  • Training and implementation
    High trainee participation and markedly less crossover in the video group (3% vs 29%) support a plausible benefit through improved visualisation and supervision; however, implementation requires equipment availability, staff training, and integration into local airway bundles.

Controversies & Subsequent Evidence

  • Pre-VODE neonatal evidence was dominated by smaller and heterogeneous studies (including teaching-focussed trials and anaesthesia settings), limiting certainty regarding physiologic harms and generalisability to urgent delivery room/NICU intubations.12
  • Design features that may influence effect size include post-randomisation exclusions due to deferred consent (12/226), an open-label setting with potential “teaching/supervision” amplification for video laryngoscopy, and substantial crossover away from direct laryngoscopy (29% vs 3%).
  • Post-VODE systematic reviews incorporating larger pragmatic data continue to show improved first-pass success with video laryngoscopy, while effects on hypoxaemia/bradycardia and clinically important downstream outcomes remain less certain due to imprecision, inconsistent outcome definitions, and risk-of-bias concerns.2
  • Contemporary resuscitation guidance now explicitly includes video laryngoscopy as an option for newborn endotracheal intubation, reflecting the evolving evidence base and potential training advantages.345
  • Large observational datasets and video-based technique analyses demonstrate persistent variation in intubation performance and complications, and suggest that effective implementation may require explicit training and technique standardisation rather than device substitution alone.67

Summary

  • In 214 urgent neonatal intubations, video laryngoscopy increased successful first-attempt intubation (74% vs 45%; P<0.001).
  • Procedural difficulty proxies favoured video laryngoscopy (median 1 attempt to success; crossover 3%) vs direct laryngoscopy (median 2 attempts; crossover 29%).
  • Physiologic compromise remained frequent; median lowest oxygen saturation was 74% vs 68%, while major resuscitation interventions were uncommon and similar (chest compressions 6% vs 5%; epinephrine 3% vs 1%).
  • Internal validity is tempered by unblinded delivery, post-randomisation consent-related exclusions (12/226), and descriptive (often post-hoc) secondary outcomes.
  • Updated evidence syntheses and recent resuscitation guidance increasingly support a role for video laryngoscopy, particularly where supervision and training are central to clinical delivery.

Overall Takeaway

VODE is a pragmatic neonatal airway RCT demonstrating that first-attempt video laryngoscopy can markedly increase first-pass intubation success during urgent newborn intubations, with no signal of excess major resuscitation interventions. Its “landmark” value lies in providing comparatively large, real-world randomised evidence in a procedure where failure-related harm is immediate, while also highlighting that desaturation and bradycardia remain common and that implementation (training, supervision, crossover behaviour) is central to translating device benefits into safer practice.

Overall Summary

  • Video laryngoscopy improved first-attempt success (74% vs 45%).
  • Serious escalation events were uncommon and similar (chest compressions 6% vs 5%; epinephrine 3% vs 1%), but desaturation was frequent.
  • Interpretation should account for open-label delivery, consent-related post-randomisation exclusions, and substantial crossover away from direct laryngoscopy.

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