Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03142997 |
| Other study ID # |
N-24-2017 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 4, 2017 |
| Last updated |
December 3, 2017 |
| Start date |
April 20, 2017 |
| Est. completion date |
September 15, 2017 |
Study information
| Verified date |
December 2017 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This is an observational study to compare the effect of spontaneous ventilation versus
controlled ventilation on lung atelectasis using lung score measured by lung ultrasound. the
study will be conducted in children hospital of Cairo University Hospitals and study
population will be : children aged from one to eight years of age. primary outcome will be
the lung score measured by lung ultrasound.
Description:
Randomization will be done by computer generated numbers and concealed by serially
numbered,opague and sealed envelopes. The details of the series will be unknown to the
investigators and the group assignment will be kept in asset of sealed envelopes each bearing
only the case number on the outside. Prior to surgery the appropriate numbered envelopes will
be opened by the nurse, the card inside will determine the patient group. All children will
be premedicated with oral midazolam 0.5mg/kg half hour before procedure and atropine at a
dose of 0.01-0.02 mg/kg (IM). Continuous electrocardiogram (ECG), pulse oximetry,
non-invasive arterial blood pressure, and temperature monitoring will be applied and all
patients will be induced with inhalational anesthetic using Sevoflurane+ oxygen (O2) with mac
6%. After deepening of the anesthesia, intravenous (I.V.) line will be inserted and fentanyl
1μg/kg. Patient will be divided into two groups; group S (spontaneous) will be intubated and
maintained spontaneously with Ayres T piece circuit on isoflurane + oxygen with mac 2% and
with fresh gas flow 2 times minute ventilation of patient to avoid co2 rebreathing . Group C
(controlled) will receive muscle given in the form of atracurium 0.5mg/kg and patients will
be intubated by appropriate size of endotracheal tube. Patients in controlled group will be
ventilated at 6 ml/ kg tidal volume, Inspiratory to expiratory (I: E) ratio 1:2, Fio2 1 and
PEEP 5 cmH2o.
10 minutes after induction lung ultrasound will be done to assess lung score and arterial
blood gases will be withdrawn. At the end of surgery lung ultrasound (LUS) will be done again
and another blood gases will be taken.
LUS will be performed with the portable echograph MicroMax (SonoSite, M-turbo) using a linear
probe of 3 to 6 MHz. Each hemithorax will be divided into six sections using three
longitudinal lines (parasternal, anterior, and posterior axillary) and two axial lines, one
above the diaphragm and another one 1 cm above the nipples.
As LUS provides regional information, we will repeat the following examination sequence in
each hemithorax and in all patients: (1) anterior, (2) lateral, and (3) posterior regions
starting from the diaphragm (caudal lung) and moving toward the apex (cranial lung). Each
hemithorax will be assessed using the two-dimensional classical view placing the probe
parallel to the ribs .The LUS of a normal lung shows a lung sliding (caused by the
respiratory movement of the visceral pleura relative to the fixed parietal pleura) and A
lines (repetitive horizontal reverberation artifacts generated by air within the lungs
separated by regular intervals, the distances of which being equal that between the skin and
the pleural line).
The lung ultrasound (LUS) assessment will be segmented in anterior , lateral (L) and
posterior (P) regions in both lungs. The dotted black axial line separated the lungs in
superior and inferior portions. Ovals depicted where the probe is placed in the classical LUS
approach: mid-clavicular, lateral and posterior axillary lines.
Anesthesia-induced atelectasis would be associated with the following LUS signs:
- Localized iso- or hypoechoic areas as compared with the highly reflective or anechoic
normally aerated lung tissue.21-25 This consolidation or tissue-like pattern is caused
by a loss of lung aeration. It commonly arises from the pleural line and thus can be
described as Juxtapleural consolidations of various sizes.
- Static air bronchograms are observed as bright echogenic branching structures within
these lung consolidations.
- The juxtapleural consolidations commonly erases the typical normal A lines and a few
focal B lines (vertical, laser-like lines that erase normal A lines) can be observed
below them.
- The lack of local respiratory movement or lung sliding and the presence of the pulse
sign (a small motion within the lungs caused by the transmission of heart beats through
the atelectatic area) are sometimes observed in large atelectatic areas.
Patients' demographic data will be collected; age, gender, weight, height, type of surgery
and duration of surgery.
Lung ultrasound examinations will be performed at different time-points 10 minutes after
induction of general anesthesia and before extubation to detect lung atelectasis. Arterial
blood samples will be collected simultaneously to measure Pao2.
Atelectasis will be assessed by ultrasound using lung aeration score applied for each region.
Lung score is four points (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration
loss, 3 = complete aeration loss and consolidation) so, applying score for 12 regions
bilateral will result in maximum score 36 and lowest score 0.
Assessment of postoperative pulmonary complications like; postoperative lung collapse,
postoperative pneumonia.
