Clinical Trial: Spontaneous Ventilation Versus Controlled Ventilation on Lung Atelectasis in Children.
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Effect of Spontaneous Ventilation Versus Controlled Ventilation on Lung Atelectasis Assessed by Lung Ultrasound in Children.
Brief 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.
Detailed Summary:
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10 minutes after induction lung ultrasound will be done to assess lung score and arterial blood gases will be withdrawn.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 secti
Sponsor: Cairo University
Current Primary Outcome: Arterial oxygen tension (Pao2) [ Time Frame: 10 minutes following induction of general anesthesia ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The lung aeration score [ Time Frame: 10 minutes following induction of general anesthesia ]lung ultrasound will be per formed on 6 areas on each hemi-thorax and the total score will be calculated (from 0-3 on each area, so the total will be 36 maximum).
- Correlation between lung score and Pao2. [ Time Frame: 10 minutes following induction of general anesthesia ]
Original Secondary Outcome: Same as current
Information By: Cairo University
Dates:
Date Received: May 4, 2017
Date Started: April 20, 2017
Date Completion: August 2017
Last Updated: May 7, 2017
Last Verified: May 2017
