Tracheomalacia in babies after correction of Esophageal Atresia - A First step to reduce respiratory morbidity

After surgical correction of esophageal atresia (EA) weakening of the windpipe
(or trachea), called tracheomalacia (TM), often occurs. TM can lead to a wide
spectrum of respiratory morbidity. Severe TM is found in in up to 33% of EA
patients. A rigid direct laryngeotracheobronchoscopy (dLTB) and flexible
tracheobronchoscopy (fLTB) under general anesthesia are routinely performed
prior to the correction of EA to assess the extent of the collapse and the
presence of other possible concomitant airway anomalies. It is, however, not
standard procedure to determine the severity of TM after the surgery. Current
practice is a wait-and-see policy to determine if patients develop complaints
of blue spells and recurrent respiratory infections. Then, patients will be
brought to the operating room to evaluate the presence and degree of TM, after
which treatment can be initiated. If it is practicable to evaluate the trachea
for TM at an earlier stage, such as during planned extubation, then treatment
for TM can be initiated at this earlier stage, before severe complaints occur
and/or before consequences of respiratory morbidity occur.

The main objective is to research the practicability of postoperative fLTB
through the endotracheal tube, right before/during planned extubation in the
intensive care unit (ICU) in newborn babies after EA correction.

This study will be a multicenter, non-therapeutic, intervention study. After
surgical repair of EA, a post-operative fLTB will be carried out right
before/during planned extubation. The fLTB will be done through the
endotracheal tube at the neonatal or pediatric ICU. The fLTB will be recorded
for detailed assessment by two otolaryngologists. The practicability of this
study intervention will be investigated by assessing if fLTB right
before/during planned extubation can be performed completely and if TM can be
assessed systematically.

After surgical repair of EA, a post-operative fLTB will be carried out right
before/during planned extubation. The fLTB will be done through the
endotracheal tube at the neonatal or pediatric ICU.

After their surgical correction, the patient will undergo the postoperative
fLTB during planned extubation, in the neonatal or pediatric ICU with local
anaesthesia. The patient will be monitored carefully, as is routine during
planned extubation. Although complications, such as laryngo- or bronchospasm
and desaturations can occur, fLTB is at present a routine procedure
pre-operatively and is associated with a low rate of complications in neonates.
To reduce the risk of adverse events for the postoperative fLTB, a clinical
assessment will be made prior to the procedure to evaluate if it is safe for a
patient to undergo this procedure, otherwise the fLTB will not be performed.
The goal of this study is to determine if it is doable to perform a fLTB
through the endotracheal tube in the ICU to establish the presence of
postoperative TM right before/during planned extubation so that the burden to
the patient is minimized. In current practice, when an infant postoperatively
develops symptoms of substantial TM (i.e. blue spells, recurrent respiratory
tract infections), the infant is taken back to the operating room to undergo a
rigid dLTB under general anesthesia. When TM is then established, treatment
(mostly supportive, sometimes surgical) is commenced, but at that moment,
possible adverse events may have already occurred. However, if it is doable to
evaluate the trachea for TM at an earlier stage, such as right before/during
planned extubation, future studies could be designed with the aim to predict
which patients will develop severe symptomatic TM.

In short, if postoperative fLTB is confirmed to be doable right before/during
planned extubation in the ICU ward, this could benefit the EA patients because:
1. Minimizing burden: It is performed right before/during the already planned
extubation (no need to return to the operating room for a rigid dLTB)
2. Possibly earlier start in treatment of severe TM (no wait-and-see policy to
develop respiratory morbidity)
3. Possibly enable studies focussed on predicting which patients will develop
severe TM by using the outcomes of the fLTB measurements before and after EA
correction.