Nasal Intermittent Positive Pressure Ventilation During Neonatal Intubation

NCT06549283 | Completed

• 1 other identifier: MSKU-NICU-OI-01
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 2

Brief Summary

The study aims to determine whether the use of nasal intermittent positive pressure ventilation (NIPPV) during neonatal endotracheal intubation increases the rate of successful intubation without physiological instability during all intubation attempts. The present study was designed as a prospective, multicenter, randomized, controlled study conducted with neonates undergoing endotracheal intubation. The infants were assigned randomly to either the NIPPV group or the standard care group.

Conditions

Respiratory Distress Syndrome; Intubation; Difficult or Failed; Newborn Morbidity; Desaturation of Blood; Ventilator Lung; Newborn

Outcome Measures

Primary Outcomes (1)

• Successful intubation without physiological instability during all intubation attempts

  Successful intubation was defined as the placement of an endotracheal tube in the trachea, confirmed based on chest elevation, auscultation, second independent laryngoscopy, carbon dioxide detection, and/or chest radiography. Physiological instability was defined as severe desaturation (a decrease of \>20% in oxygen saturation relative to that immediately prior to pre-laryngoscopy) or bradycardia (a heart rate of \<100 beats per minute) during the intubation attempts. All intubation attempts was defined as the requirement for single, two, or multiple attempts for successful intubation.

  One year

Secondary Outcomes (7)

• Lowest SpO2 level

  One year

• Lowest heart rate

  One year

• Bradycardia

  One year

• Severe desaturation

  One year

• Successful intubation on the first attempt without physiological instability

  One year

Study Arms (2)

NIPPV group

ACTIVE COMPARATOR

Nasal intermittent positive pressure ventilation (NIPPV) was implemented during the entire intubation process (pre-intubation to intubation to the end of successful intubation). Appropriately-sized bi-nasal cannulae were placed prior to laryngoscopy as interface for NIPPV implementation. Non-synchronized NIPPV was implemented. NIPPV was initiated prior to intubation, with the peak inspiratory pressure set to 16-20 cmH2O (selected according to the infant's birth weight and chest wall expansion), positive-end expiratory pressure set to 6 cmH2O, breathing rate set to 40-50 breaths/min, inspiratory time set to 0.40-0.45 s, and flow rate set to 8-12 L/min. After the first successful intubation attempt, NIPPV was discontinued. Prior to laryngoscopy, the fraction of inspired oxygen (FiO2) was adjusted to maintain SpO2 above 90%.

Device: Nasal intermittent positive pressure ventilation (NIPPV) via binasal cannula during neonatal intubation

Standard-care group

NO INTERVENTION

The intubation attempt proceeded without NIPPV or supplemental oxygen.

Interventions

Nasal intermittent positive pressure ventilation (NIPPV) via binasal cannula during neonatal intubation DEVICE

Researchers applied NIPPV treatment using binasal cannulas through a mechanical ventilator during intubation.

NIPPV group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants of a gestational age of 22-41 weeks and undergoing oral endotracheal intubation in the neonatal intensive care within the first 28 days of life

You may not qualify if:

• The infants who required urgent intubation,
• Infants intubated in the delivery room or the operating room,
• Infants with a heart rate of \<120/min prior to randomization,
• Infants with airway or lung anomalies,
• Infants with cyanotic congenital heart disease,
• Infants NIPPV treatment was contraindicated (congenital nasal anomaly, congenital diaphragmatic hernia, or abdominal wall defect)

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (2)

Mugla Training and Research Hospital, Department of Neonatology

Menteşe, Muğla, 48000, Turkey (Türkiye)

Location

Akdeniz University School of Medicine, Department of Neonatology

Antalya, 07000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ozkan Ilhan, Assoc Prof

  Muğla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The patients were divided into two groups: the NIPPV group and the standard care group. In the NIPPV group, NIPPV was implemented during the entire intubation process (pre-intubation to intubation to the end of successful intubation). In the standard care group, the intubation attempt proceeded without NIPPV or supplemental oxygen.

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: July 15, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)