The overall aim of this observational prospective study is to evaluate the association between a) the trajectory of cerebral oxygenation, activity and perfusion as evaluated by NIRS, aEEG, Zonare Doppler Ultrasound and Cytocam-IDF during and 24…
ID
Source
Brief title
Condition
- Gastrointestinal tract disorders congenital
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The overall aim is to evaluate the association between cerebral oxygenation,
activity and perfusion as evaluated perioperative by NIRS, aEEG, Zonare Doppler
Ultrasound and Cytocam-IDF and evaluation of growth and neurodevelopment within
the first two years of age.
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Secondary outcome
* Evaluation by NIRS, aEEG, Zonare Doppler ultrasound and Cytocam-IDF to
compare open, minimal access surgery (MAS) and conversion from MAS to open
surgery of the diaphragm defect for 24 hours.
* Transcutaneous CO2 measurements
* Mitochondrial saturation
* Pre- and postoperative intensive care management:
* Ventilation settings and need of oxygen
* Use of vaso-active medication
* (Postoperative) pain scores every eight hours (COMFORT scores)
* Number of ventilator free days at day 28
* Length of stay (LOS)
* Prenatal screening ultrasound results for CDH neonates
* Cranial ultrasound pre- and postoperative, at discharge from paediatric centre
* Arterial blood gas analysis perioperative
* Contralateral renal and quadriceps muscle tissue oxygenation starting 3 hours
before surgery till 24 hours postoperative
* Recurrence rate in the two years after surgery
* Neurodevelopmental outcome at 6, 12, 18 and 30 months of age
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Background summary
Neonatal circulatory homeostasis is influenced by multiple factors in the
perioperative period and general anesthesia affect the hemodynamics negatively
during surgical repair. Traditional surgical management of CDH consists of
repair by laparotomy and for EA by thoracotomy. In the last decade, minimal
access surgery (MAS) became more popular because literature reports less
surgical stress, faster recovery and shorter hospitalization after MAS.
Therefore, thoracoscopic repair of CDH and EA is still being further explored.
A number of centres perform thoracoscopic repair when patients are
cardiopulmonary stable. Cardiopulmonary stability criteria still differ between
centres and have been published in nine retrospective studies. Patients who do
not fulfil the criteria will undergo open repair. Neonates are prone for
intraoperative acidosis regarding type of surgery, due to the intrathoracic
manipulation by the surgeon a ventilation-perfusion mismatch may arise. During
minimal invasive thoracoscopic surgery with CO2 insufflation and a
pneumothorax, the acidosis is more severe. The anesthesiologist aims to
compensate this acidosis by adapting the ventilation with increased tidal
ventilation. This results in a higher mean ventilation pressure which is
associated with a compromised venous return with decreased right ventricle
preload. The aim of optimized CO is to maintain adequate tissue perfusion and
oxygenation.
The artificial pneumothorax, mechanical pressure and acidosis may affect tissue
perfusion in general. Quantitative analysis of this effect has always been
difficult. Bishay et al. showed substantial arterial blood gas changes during
thoracoscopic repair in CDH and EA, but this finding was based on only ten
patients. Our pilot study showed severe respiratory acidosis with changes in
tissue perfusion. This is seen on macro- (Doppler ultrasound), micro-
(microcirculation) and cellular (mitochondrial saturation) level.
Therefore, in patients with CDH and EA (particularly those with a good
prognostic outcome) it is not clear whether the balance between pros and cons
of MAS is in favour or against its use. One particular aspect relates to the
long-term outcomes of MAS in CDH and EA. Neurodevelopmental outcome, especially
in the long term, is still under documented. We do know however, that
neurodevelopment rests on complex interactions between preoperative,
perioperative and postoperative events. This might be related to factors such
as the surgical procedure itself, effects of anaesthetic medication and
perioperative hypoxic/ischemic brain injury. Neurodevelopmental outcome may be
influenced by the use of different surgical and anaesthesiological
techniques.
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Study objective
The overall aim of this observational prospective study is to evaluate the
association between a) the trajectory of cerebral oxygenation, activity and
perfusion as evaluated by NIRS, aEEG, Zonare Doppler Ultrasound and Cytocam-IDF
during and 24 hours after surgery and b) long-term psychomotor outcome as
evaluated by CHIL-follow up at age 2. In addition, evaluation of changes in
cerebral oxygenation, activity and perfusion as evaluated by NIRS, aEEG, Zonare
Doppler Ultrasound and Cytocam-IDF and a comparison between open and minimal
access surgery of the diaphragm/esophageal defect. The analysis will help to
determine whether neuromonitoring outcomes should be used to determine whether,
and for which patients, minimal access surgery is safe.
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Study design
Multi-centre observational prospective study.
Study burden and risks
Subjects will have no direct benefits of participating in this study. The
neuromonitoring is non-invasive. The surgical technique is regularly performed
in our departments. The burden for the patient is expected to be very low.
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
Surgical repair should be performed after clinical stabilization, defined as
follows:
* Mean arterial blood pressure normal for gestation.
* Preductal saturation levels of 85-95% on FiO2 below 50%
* Lactate below 3 mmol/l
* Urine output more than 1 ml/kg/h
Repair can be performed while the patient is on ECMO
Exclusion criteria
Associated major cardiac anomalies/chromosomal anomalies or syndromes with
major cognitive impairment excluding surgical repair of the
diaphragmatic/esophageal defect due to futility.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL59526.078.17 |
Other | NTR TC=7160 |