Primary pOsterioR TRacheopexy Prevents Collapse of the Trachea in Newborns With Oesophageal AtresIa and Tracheomalacia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- UMC Utrecht
- 入组人数
- 78
- 试验地点
- 6
- 主要终点
- Difference in degree of TM between the PPT-group and no-PPT-group during intraoperative tracheobronchoscopy
研究概览
简要总结
Introduction: Children born with a blind-ending gullet (oesophagus), or Oesophageal Atresia (OA), need to undergo surgical correction in the first week of life. OA is often accompanied by a weakened windpipe (trachea), known as tracheomalacia (TM). TM entails that the windpipe collapses during expiration. Severe TM can cause respiratory symptoms, including frequent respiratory tract infections and blue spells, that can potentially lead to life-threatening events. In some patients, major secondary surgical treatment may be indicated. This surgical procedure involves widening the trachea (using sutures) to prevent collapse, known as secondary posterior tracheopexy (SPT). Prior to performing this SPT, complications and negative consequences of TM may have already occurred. This may be prevented by performing this procedure during the primary OA correction, called a primary posterior tracheopexy (PPT). The aim of this trial is to determine if a PPT can decrease - or prevent - tracheal collapse in newborns with OA and TM, compared to a wait-and-see policy (no-PPT).
Methods: This is an international multicentre double-blind randomised controlled trial. Seventy eight children with OA type C will be included. Patients will be included after written parental informed consent. Half of the patients will be randomly allocated to the PPT-group and half to the no-PPT-group. The degree and location of TM are evaluated through preoperative, intraoperative and two postoperative videoscopic examinations of the trachea (tracheobronchoscopy). Whether TM symptoms occur is assessed during three routine follow-up consultations until the age of 6 months. The primary outcome is the degree of collapse of the tracheal wall during the intraoperative tracheobronchoscopy (after performing the PPT/no-PPT), measured in percentages.
Risks and burden: Since OA correction with PPT (more recently implemented in centres of expertise) and without PPT (wait-and-see policy) are both accepted and safe treatment options, participating in the trial does not pose an increased risk or burden with regards to the treatment. Performing tracheobronchoscopies may pose a potential burden. However, a tracheobronchoscopy is a routine diagnostic procedure commonly used to safely assess the trachea. Complications of a tracheobronchoscopy are rare. Also, many of the tracheobronchoscopies are routinely performed as part of standard care for these patients, regardless of the trial.
详细描述
Rationale:
A congenital blind-ending gullet (oesophagus), or Oesophageal Atresia (OA), is very often accompanied by a weakened windpipe (trachea). This is known as tracheomalacia (TM) and entails that the windpipe collapses during expiration. Severe TM can cause increased respiratory morbidity, including frequent respiratory tract infections and blue spells, that can potentially progress to respiratory arrest. Respiratory morbidity poses a significant burden on OA patients, both in the short term and over the course of long-term follow-up. When severe TM is identified, surgical intervention may be necessary. This surgical procedure involves widening the trachea (using sutures) to prevent its collapse, known as a posterior tracheopexy (PT). Prior to performing this secondary PT (SPT), complications and sequelae of TM may have already manifested. Additionally, performing this PT as a secondary operation after the OA correction is a complex surgical procedure in newborns, and poses a significant risk of damaging the recently performed OA anastomosis. This separate, SPT requires several hours of surgery, due to the presence of extensive adhesions. As a result, there has been a growing trend to carry out the PT concurrently with the initial correction of OA, known as a primary posterior tracheopexy (PPT). Previous studies have shown a decrease in respiratory tract infections (RTI's) and brief respiratory unexplained events (BRUE's) following the implementation of a PPT, when compared to patients who did not undergo PPT. However, it is important to note that these studies were predominantly conducted at a single medical center and relied mostly on retrospective data analysis. To address several sources of bias, such as center-specific factors, selection-bias and information bias, a double-blind randomized controlled trial should be conducted.
To accurately evaluate the effects of PPT versus no-PPT (i.e. the percentage of tracheal wall collapse) a tracheobronchoscopy needs to be performed, as it is the only objective measure for this purpose. Tracheobronchoscopy allows for a direct visual examination of the trachea, with a minimal effect on normal airway dynamics, ensuring a reliable evaluation of the impact of the PPT on the tracheal diameter.
Objective: The aim of this trial is to evaluate if a PPT can significantly decrease - or possibly prevent - the collapse of the trachea in newborns with OA and TM, compared to a wait-and-see policy (no-PPT). Additionally, the trial aims to determine whether the observed effect of PPT on tracheal stability is sustained over time.
Design and methodology:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
All participants, parents/caregivers, investigators and treating healthcare personnel, except for the surgical team performing the OA correction, will be blinded to which study arm the participant is assigned. None of the data gathered is affected by the unblinded surgical team since the primary and key secondary outcome measures are evaluated based on pseudonymised video footage. Furthermore, this video footage is assessed by otolaryngologists who are blinded to the patient and study arm. Moreover, the follow-up and documentation of the secondary endpoints are typically performed by the paediatrician and speech- and language therapists (not the paediatric surgeon or otolaryngologist).
入排标准
- 年龄范围
- 34 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmed diagnosis of OA with a distal TOF
- •Tracheomalacia
- •Written informed consent by both parents or legal representatives
排除标准
- •Patients with OA without a distal TOF
- •Premature neonates <34 weeks
- •Endotracheal tube size < 3.0
- •Cormack score 3 or 4 as scored by either the otolaryngologist, anesthesiologist, or neonatal/pediatric intensive care specialist
- •Patients with a cyanotic cor vitium
结局指标
主要结局
Difference in degree of TM between the PPT-group and no-PPT-group during intraoperative tracheobronchoscopy
时间窗: Measured by an intraoperative tracheobronchoscopy performed after freeing the trachea and oesophagus (and the PPT) but before the surgical correction of OA, through the ventilation tube
The difference in the degree of tracheal collapse between the PPT and the no-PPT group measured in percentage of the tracheal diameter
次要结局
- Degree of preoperative TM compared to postoperative TM(Comparison between the measurements during the preoperative tracheobronchoscopy and the postoperative tracheobronchoscopy at 2-6 months postoperative.)
- Difference in symptoms between the PPT-group and no-PPT-group(During follow-up, starting at the first follow-up consultation at 2-3 months, until the last follow-up consultation at 6 months.)
- Key secondary outcome: Difference in degree of TM between the PPT-group and no-PPT-group during postoperative tracheobronchoscopy(Measured by a tracheobronchoscopy performed during extubation (approximately 1 day after surgery) and by a tracheobronchoscopy 2-6 months after surgery.)
研究者
Maud Lindeboom
Principal investigator
UMC Utrecht