Pressure Support Ventilation Versus Continuous Positive Air Way Pressure (CPAP) Using I Gelin Adult Patients,

Study Overview
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Brief Summary
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Introduction of Supra glottic airway devices (SAD) has revolutionized the airway management. The first successful supraglottic airway device, the Laryngeal Mask Airway(LMA).The various other SADs include ProSeal LMA, Intubating LMA and i-gel to overcome the limitations of classic Laryngeal Mask Airway( c-LMA) The risk of aspiration with c-LMA is reported tobe around 9% , pleaseboth the c-LMA and PLMA have cuff related complications. High cuff pressure in laryngeal mask airways can cause damage to the mucosae on periglottic and supraglottic structures . Therefore, to overcome the limitations of Pro Seal Laryngeal Mask Airway (PLMA )a new and cheaper SAD called i-gel was developed. i-gel is a novel and innovative, latex free supraglottic device, made up of medical grade thermoplastic elastomer, which is soft, gel like, transparent The number of manipulations required are more in PLMA than i gel resulting in hemodynamic changes .The i-gel is comparable to PLMA insuring the airway during controlled ventilation. It is better than PLMA in terms of ease of insertion. Spontaneous breathing is the most popular mode of ventilation with the laryngeal mask airway (LMA), but it provides less effective gas exchange than does positive pressure ventilation (PPV) . The patients receiving sevoflurane anesthesia with unassisted ventilation have a reduced rib cage contribution to ventilation, decreased tidal volume, and respiratory rate . Pressure support ventilation (PSV) is a ventilator mode that is initiated by the patient and synchronized with the patient's respiratory effort. And may improve gaseous exchange in patients. In the intensive care unit, it is often considered the preferred mode for weaning mechanical ventilation .PSV provides more effective gas exchange than does unassisted ventilation with CPAP during anesthesia with the LMA while preserving hemodynamic homeostasis. The use of PSV versus CPAP with the Pro Seal laryngeal mask airway in anesthetized pediatric patients revealed that PSV improved gaseous exchange and reduced work of breathing during general anesthesia PSV via Pro- Seal laryngeal mask airway improves gaseous exchange and ventilation in pediatric patients under general anesthesia more than spontaneous ventilation .

Detailed Description
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Patients and Methods This prospective,cross over study will be conducted after obtaining approval from the Institutional Review Board (IRB) of faculty of medicine Mansoura University. A written informed consent will be obtained from all participants and the duration of the study will be 2 - 6 months. Participants: 38 Adult patients with American Society of Anesthesiologists (ASA) physical status (I - II )of both sexes aged (18-65) years scheduled for minor surgery at Urology and Nephrology centre (UNC) will be included in this study. The Patients with a body mass index (BMI) >40 or having obstructive air way disease will be excluded. All patients will be assessed on the day before surgery by detailed history thorough clinical examination, and basal laboratory investigations [Complete blood count (CBC), Coagulation profile (prothrombin time and INR), liver and renal function tests (liver enzymes, bilirubin, albumin and s. creatinine], electrocardiograph (ECG) and echo cardiography when needed. Anaesthesia Induction of anaesthesia with fentanyl 0.5µg/kg - propofol 1mg/kg prior for insertion of device,primary success rate will be recorded. Maintenance of anaesthesia by sevoflurane inhalation with minimal alveolar concentration (MAC) 2%. All patients will breath spontaneously from ventilators (Dragers - Primal - germany). All patients will breath at the first 15 minutes with PSV:triggered by minute volume <3 liter,with no frequency then the following 15 minutes ventilation will be changed to CPAP mode at 10 cm H2o . Monitoring: (basal& every 3minutes) Tidal volume (inspiratory & expiratory). End tidal co2. Mean air way pressure. Leakage %. Respiratory rate . Spo2. Heart rate. Blood pressure (mean arterial pressure). Adverse effects;Laryngeal spasm.Blood stained device. .

Official Title
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Pressure Support Ventilation Versus Continuous Positive Air Way Pressure (CPAP) Using I Gel Laryngeal Mask for Minor Surgery in Adult Patients, a Prospective cross_over Study

Conditions
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Ventilator Lung

Intervention / Treatment
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* Device: the first 15 minutes with pressure support ventilation
* Device: the following 15 minutes ventilation will be changed to continous positive air way pressureCPAP mode
* Device: i gel air way


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with (ASA) physical status I - II years scheduled for minor surgery at Urology and Nephrology centre (UNC) will be included in this study. Exclusion Criteria: The Patients with a body mass index (BMI) >40 or having obstructive air way disease will be excluded.•

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: a prospective cross_over study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: the first 15 minutes with PSV<br>All patients will breath at the first 15 minutes with PSV:triggered by minute volume <3 Liter,with with no frequency . Monitoring: (basal&every 3minutes) Tidal volume (inspiratory & expiratory). End tidal co2. Mean air way pressure. Leakage %. Respiratory rate . Spo2. Heart rate. Blood pressure (mean arterial pressure | Device: the first 15 minutes with pressure support ventilation<br>* PSV pressure support ventilation:triggered by minute volume < 3 Liter ,with no frequency<br>* Other names: lung mechanical ventilatory mode on mechanical ventilator;Device: i gel air way<br>* supraglottic air way device<br>|
| Active Comparator: the following 15 minutes ventilation will be changed to CPAP mode<br>then the following 15 minutes ventilation will be changed to CPAP mode at 10 cm H2o . Monitoring: (basal&every 3minutes) Tidal volume (inspiratory & expiratory). End tidal co2. Mean air way pressure. Leakage %. Respiratory rate . Spo2. Heart rate. Blood pressure (mean arterial pressure). | Device: the following 15 minutes ventilation will be changed to continous positive air way pressureCPAP mode<br>* continous positive air way pressure CPAP mode at 10 cm H2o .<br>* Other names: lung mechanical ventilatory mode on mechanical ventilator;Device: i gel air way<br>* supraglottic air way device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective ventilation with PSV than does (CPAP) as regard Tidal volume | Breathing of all patients at the first 15 minutes with PSV pressure support ventilation:triggered by minute volume <3 liter,with no frequency then the following 15 minutes ventilation with CPAP .ventilation will be measured by Monitoring: (basal& every 3minutes)Tidal volume (inspiratory & expiratory).on ventilator monitor in mil/ kilogram | 30 minutes | 
| Effective ventilation with PSV than does (CPAP) as regard End tidal co2. on ventilator | Breathing of all patients at the first 15 minutes with PSV pressure support ventilation:triggered by minute volume <3 liter,with no frequency then the following 15 minutes ventilation with CPAP.ventilation will be measured by Monitoring: (basal& every 3minutes) End tidal co2. on ventilator ml/eq | 30 minutes | 
| Effective ventilation with PSV than does CPAP as regard Mean air way pressure | Breathing of all patients at the first 15 minutes with PSV pressure support ventilation:triggered by minute volume <3 liter,with no frequency then the following 15 minutes ventilation with CPAP.ventilation will be measured by Monitoring: (basal& every 3minutes) Mean air way pressure.on ventilator mmhg | 30 minutes | 
| Effective ventilation with PSV than does (CPAP) as regard Leakage % | Breathing of all patients at the first 15 minutes with PSVpressure support ventilation:triggered by minute volume <3 liter,with no frequency then the following 15 minutes ventilation with CPAP.ventilation will be measured by Monitoring: (basal& every 3minutes) Leakage % on ventilator monitor | 30 minutes | 
| Effective ventilation with PSV than does CPAP as regard oxygen saturation. | Breathing of all patients at the first 15 minutes with PSV pressure support ventilation:triggered by minute volume <3 liter,with no frequency then the following 15 minutes ventilation with CPAP.ventilation will be measured by Monitoring: (basal& every 3minutes) oxygen saturation.on monitoring in % | 30 minutes | 
| Effective ventilation with PSV than does (CPAP) as regard respiratory rate | Breathing of all patients at the first 15 minutes with PSV pressure support ventilation:triggered by minute volume <3 liter,with no frequency then the following 15 minutes ventilation with CPAP .ventilation will be measured by Monitoring: (basal& every 3minute)respiratory rate on monitor breath/ minute | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pressure support ventilation (CPAP) I gel