Gestational Age Versus Nasal-tragus Length for Estimating Endotracheal Tube Insertion Depth in Newborns - A Randomised Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 454
- 试验地点
- 4
- 主要终点
- Proportion of infants with optimally positioned endotracheal tube tip on the chest X-ray
研究概览
简要总结
Endotracheal intubation is a life-saving intervention that few infants need after birth. Although an endotracheal tube is the most reliable way of providing positive-pressure breath, the critical factor that determines the maximal efficacy of positive-pressure ventilation is the optimal placement of the endotracheal tube tip. There are various methods available to determine the initial depth of endotracheal tube (ETT) that are based on the infant's birth weight, gestational age, anthropometric measurements, and others include vocal cord guide and suprasternal palpation methods.
The Neonatal Resuscitation Program (NRP) textbook, in its 7th edition of the textbook, recommends a gestational age chart and nasal-tragus length method for estimating endotracheal tube insertion depth during cardiopulmonary resuscitation of the neonate. The evidence to support these two methods is, however, limited. Hence, we designed this study to determine the accuracy of two methods, gestational age chart and nasal-tragus length method, recommended by the Neonatal Resuscitation Program.
详细描述
Trial Objective: To determine whether estimating ETT insertion depth using gestational age chart rather than nasal-tragus length method results in more correctly positioned ETT tips.
Setting: The neonates will be recruited from multiple tertiary-level neonatal intensive care units in Saudi Arabia. A neonate can participate in more than one clinical trial, depending on the interventions being given. Parallel run trials will be discussed between the chief and local principal investigators whether or not joint recruitment is feasible to both parties.
Informed Consent: We will obtain written consent after the parents have been given a full verbal explanation and written description. We will explain to the parents in their own native language. We will use a hospital-based adult interpreter wherein required. We will obtain deferred consent (after initial verbal assent) where prior consent is not feasible as the study does not involve additional risk or investigations to the participants, and the interventions are otherwise considered as standard practice recommendations by the NRP.
Data Safety Monitoring Board: Any unexpected serious events (death, any life-threatening event, any event that will prolong the hospitalization or any event that will result in disability) will be reported to the data safety monitoring committee. The trial steering committee will receive recommendations from the data safety monitoring board if the trial requires early termination following the interim data analyses and evidence from relevant studies. The following measures were agreed to consider stopping the trial, wholly or partly (subgroups), after an interim analysis, that will be done after recruiting 200 participants.
- An absolute difference of greater than or equal to 25% in the primary outcome between the study groups.
- An absolute difference of less than 5% in the primary outcome between the study groups.
- A rate of less than 20% in the primary outcome in either of the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding of the clinicians, nurses, and patient caregivers are impractical. However, to minimize the bias, we will neither mention the method used to estimate the endotracheal tube insertion depth to the patient caregivers explicitly and nor record in the patient charts. We will blind the primary outcome assessment by masking the consultant pediatric radiologist to the group assignment. Similarly, the consultant pediatric radiologist will determine the following secondary outcomes-endotracheal tube tip above the upper border of T1 vertebra, endotracheal tube tip below the lower border of T2 vertebra, and pneumothorax. The other secondary outcomes (endotracheal tube repositioning after the X-ray, oxygen therapy at 28 days, oxygen therapy, or positive pressure support at 36 weeks post-menstrual age, duration of invasive ventilation, and death before discharge) will be determined by the trained research assistant.
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants (less than 28 days of life) between 23 weeks 0 days and 41 weeks 6 days gestational age
- •Infants requiring oral intubation in the delivery room or in neonatal intensive care unit
排除标准
- •Infants with major chromosomal anomalies, including trisomy 13, trisomy 18, and trisomy 21
- •Infants with major anomalies, including craniofacial anomalies and facial dysmorphism that may affect the nasal-tragus length
结局指标
主要结局
Proportion of infants with optimally positioned endotracheal tube tip on the chest X-ray
时间窗: within 4 hours of endotracheal intubation
Endotracheal tube tip is considered optimally positioned if the tip lies between upper border of first thoracic vertebra (T1) and the lower border of second thoracic vertebra (T2) on the chest X-ray. While obtaining the antero-posterior view chest X-ray in supine position, the infant's head, neck and chest is placed in the midline with no tension on the endotracheal tube and neck being in neutral position (i.e. neck neither flexed nor extended). Just before obtaining the film, the investigator/research assistant should re-confirm that the endotracheal tube is secured in a standardize manner at the estimated depth based on the treatment arm assigned.
次要结局
- Proportion of infants with endotracheal tube tip above T1 vertebra(within 4 hours of endotracheal intubation)
- Proportion of infants with pneumothorax(36 weeks of post-menstrual age)
- Proportion of infants with requiring endotracheal tube repositioning (advance or withdrawn) following chest X-ray(24 hours)
- Ventilation days(36 weeks of post-menstrual age)
- Proportion of infants with oxygen therapy(28 days from the birth)
- Proportion of infants with endotracheal tube tip below T2 vertebra(within 4 hours of endotracheal intubation)
- Proportion of infants with bronchopulmonary dysplasia(36 weeks of post-menstrual age)
- Proportion of infants with mortality(36 weeks of post-menstrual age)
研究者
Abdul Razak
Clinical Assistant Professor
Princess Nourah Bint Abdulrahman University