Lung Recruitment and Postoperative CPAP

Study Overview
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Brief Summary
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General anesthesia lowers FRC thereby promoting airway closure and absorption atelectasis. Alveolar recruitment manoeuvers recruit collapsed alveoli, increase gas exchange, and improve arterial oxygenation.

Detailed Description
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General anesthesia lowers FRC thereby promoting airway closure and absorption atelectasis. Alveolar recruitment manoeuvers recruit collapsed alveoli, increase gas exchange, and improve arterial oxygenation. However, the effect of recruitment manoeuvre is short lasting and does not extend to the post operative period. Postoperative CPAP keeps the lung open and can improve oxygenation in the early postoperative period.

Official Title
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Lung Recruitment and Postoperative CPAP in Pediatric Laparoscopic Surgery

Conditions
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Anesthesia

Intervention / Treatment
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* Device: Engström Datex-Ohmeda ICU Ventilator
* Device: Postoperative CPAP mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients undergoing laparoscopic surgery for abdominal cryptorchidism. Exclusion Criteria: Cardio-respiratory illness. Unsatisfactory preoperative peripheral arterial oxygen saturation. Unsatisfactory preoperative hemoglobin level. Neurological or psychiatric disease. Children with a BMI >95th percentile for age.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Engström Datex-Ohmeda ICU Ventilator: Pediatric patients under general anesthesia will be mechanically ventilated with the conventional ventilator parameters with 0 PEEP/CPAP. | |
| Active Comparator: Lung Recruitment- PEEP group<br>Engström Datex-Ohmeda ICU Ventilator: Pediatric patients under general anesthesia will be mechanically ventilated with the conventional ventilator parameters plus lung recruitment manoeuvre with peak inflation pressure 35 cmH2O for 15 seconds followed by PEEP until extubation delivered by the ventilator. | Device: Engström Datex-Ohmeda ICU Ventilator<br>* patients will be mechanically ventilated and a vital capacity manoeuvre for lung inflation will be done by increasing the PIP to 35 cmH2o for 15 seconds followed by PEEP until extubation.<br>|
| Active Comparator: Lung Recruitment- PEEP and CPAP group<br>Engström Datex-Ohmeda ICU Ventilator: Pediatric patients under general anesthesia will be mechanically ventilated with the conventional ventilator parameters plus lung recruitment manoeuvre with peak inflation pressure 35 cmH2O for 15 seconds followed by PEEP until extubation delivered by the ventilator. Postoperative CPAP mask immediately after extubation | Device: Engström Datex-Ohmeda ICU Ventilator<br>* patients will be mechanically ventilated and a vital capacity manoeuvre for lung inflation will be done by increasing the PIP to 35 cmH2o for 15 seconds followed by PEEP until extubation.<br>Device: Postoperative CPAP mask<br>* patients will be mechanically ventilated and a vital capacity manoeuvre for lung inflation will be done by increasing the PIP to 35 cmH2o for 15 seconds followed by PEEP until extubation and a CPAP mask will be applied immediately postoperative.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (A-a) DO2 | arterial blood gas will be withdrawn 1 hour after extubation and the alveolar minus arterial oxygen difference will be calculated for assessment of oxygenation | 1 hour after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2 | arterial blood gas samples will be withdrawn to assess Pa O2. | intra-operative and 1hour postoperative | 
| PaCO2 | arterial blood gas samples will be withdrawn to assess PaCO2. | intra-operative and 1hour postoperative | 
| PH | arterial blood gas samples will be withdrawn to assess PH. | intra-operative and 1hour postoperative | 
| Respiratory mechanics | intra-operative ventilator data will be recorded to measure respiratory mechanics such as dynamic and statistic compliance | Intraoperative | 
| non invasive mean arterial pressure | non invasive mean arterial pressure will be recorded before and after recruitment manouvre, after pneumoperitonium and after pneumoperitonium deflation | intraoperative and 1hour postoperative | 
| Heart rate | the heart rate will be recorded before and after recruitment manoeuvre, after pneumoperitonium, and after pneumoperitonium deflation and early postoperative.. | intraoperative and 1hour postoperative | 
| Peripheral arterial oxygenation SPO2% | The SPO2% will be recorded before and after recruitment manouvre, after peumoperitoneum inflation and after pneumoperitoneum deflation and early postoperative | intraoperative and 1hour postoperative |