Airway Morbidity Clinical Trial
Official title:
A Randomized Controlled Trial Comparing Proseal Laryngeal Mask Airway, I-gel Airway and Laryngeal Tube Suction-D in Mechanically Ventilated Patients
Verified date | August 2016 |
Source | Government Medical College, Haldwani |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Aim of the study is to compare the clinical performance of p-LMA, i-gel and LTS-D in terms of the efficacy and safety in anaesthetized patient on Mechanical ventilation undergoing elective surgical procedure.
Status | Completed |
Enrollment | 150 |
Est. completion date | August 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility |
Inclusion Criteria: - American Society of Anaesthesiologists (ASA) class I/II. - Age 20-60years of either sex. - Weight between 40-60 kg of either sex. - Elective Surgical procedures of duration of 1-1½ hour with no need for endotracheal intubation. Exclusion Criteria: - Patient with risk factors for difficult airway. (Mouth opening of <2cm, Mallampati class 4, limited neck extension, history of previous difficult intubation) - Any known pulmonary and cardiovascular diseases. - Risk of aspiration. (Full stomach, hiatus hernia, gastro-oesophageal reflex disease, emergency surgery) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Government Medical College, Haldwani |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Insertion attempts | 10 mins | ||
Secondary | Grading of insertion of device by Easy or Difficult | Easy insertion is defined as no resistance to insert in first attempt. Any repeat attempt or resistance to insertion is defined as Difficult. | 10 min | |
Secondary | Time taken for placement of device | 10 min | ||
Secondary | Airway sealing pressure | 10 min | ||
Secondary | Number of attempts of gastric tube placement | 20 min | ||
Secondary | Complication | 120 min |
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