LMA Vs I Gel Clinical Trial
Official title:
Randomized Comparative Study Between Classic Laryngeal Mask Airway and I Gel Airway in Obese Patients Having BMI 35-40 During Elective Non Abdominal Surgery.
NCT number | NCT03843827 |
Other study ID # | N 34-2017/Ms |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 9, 2019 |
Est. completion date | May 18, 2019 |
Verified date | May 2019 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Invistigators study both supraglottic airway devices; the classic LMA and the I GEL mask are satisfactory devices providing high airway leaking pressures. Although both devices provide high airway leaking pressures, Invistigators study revealed that the I gel mask provides a better seal with the glottic aperture and shorter time of insertion than cLMA. Both devices showed also effective ventilation, more hemodynamic stability and no episode of hypoxia with minimal post-operative complications.
Status | Completed |
Enrollment | 50 |
Est. completion date | May 18, 2019 |
Est. primary completion date | May 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Adult healthy ASA II patients 2. both genders 3. BMI 35-40 4. aged 18 - 60 years 5. Mallampati grade I, II with airway score < 4 according to El Ganzouri score during elective non abdominal surgery = 2hour e.g diagnostic arthroscopy, hysteroscopy and cataract Exclusion Criteria: 1. ASA class III or IV 2. Age >60 years or <18 years, 3. people with hypertension, diabetes, pregnancy, gastro oesophageal reflux disease, cardiovascular ,renal disease4. difficult mask ventilation , obstructive sleep apnea ,any position rather than supine , airway score = 4 according to El Ganzouri score 5. any form of sore throat ,patients allergic to any drugs used in the study 6. PCV mode if measured tidal volume was lesser than 6 ml/kg it will be excluded. |
Country | Name | City | State |
---|---|---|---|
Egypt | Ahmed Abdalla Mohamed | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time of insertion of each device . | Invistigators study Time of insertion of each device,Laryngeal Mask Airway and I gel | Half an hour | |
Secondary | Leaking pressure of each device. | Invistigators study Leaking pressure of each device,Laryngeal Mask Airway and I gel | Half an hour | |
Secondary | Confirmation of position by fiber optic | Invistigators study Confirmation of position by fiber optic of each device,Laryngeal Mask Airway and I gel | Half an hour | |
Secondary | Blood Pressure | Investigators recorded a baseline reading of systolic blood pressure and diastolic blood pressure before insertion of both devices. A second reading was taken after insertion of both devices, just before removal. The fourth reading was recorded 1 min after removal of both devices. | 24 hours | |
Secondary | Heart Rate | Investigators recorded a baseline reading of heart rate, before insertion of both devices. A second reading was taken after insertion of both devices, just before removal. The fourth reading was recorded 1 min after removal of both devices. | 24 hours | |
Secondary | Oxygen saturation | Investigators recorded a baseline reading of Oxygen saturation before insertion of both devices. A second reading was taken after insertion of both devices, just before removal. The fourth reading was recorded 1 min after removal of both devices. | 24 hours | |
Secondary | Postoperative complications | With regard to postoperative complications, after removal of the device, post operative blood stain in laryngeal mask and I gel | 24 hours |