Efficiency of I-gel Supraglottic Airway Device in Supine and Lateral Decubitus Position in Obese Patient

NCT04119245 | Completed

• 1 other identifier: S-12-2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is linked to many complications of respiratory care which are directly related to the obstructive apnea syndrome: difficult airway management including difficult mask ventilation, difficult intubation and obstruction of the upper airway. I gel which is a non inflatablesupraglottic airway device with a gastric channel is gaining popularity in anesthesia practice because of its ease of insertion and stable positioning. There are many studies evaluating I-gel for airway managment during different head and necks position ,in prone and lateral position showing both successeful results. Morover, it was evaluated during spontanous and mechanically ventilated patients. There are limited number of studies evaluating the efficacy of I- gel in mild to moderate obese patients. The primary aim of this study is to Measure the oropharyngeal airway leak pressure in both supine and lateral position and to determine laryngeal glottic view grade by the fibreoptic bronchoscope.

Conditions

Obesity, Airway

Keywords

obesity; Igel; suraglotic device

Outcome Measures

Primary Outcomes (1)

• comparison between supine and lateral Oropharyngeal leak airway pressure

  Oropharyngeal leak airway pressure during controlled ventilation in supine position after insertion of I-gel by one minute and n lateral position after one minute from setting patient in lateral postion.

  1 minute

Secondary Outcomes (6)

• Swallowing

  5 hours

• Hoarseness

  5 hours

• Nausea and vomiting

  5 hours

• fiberoptic view in supine position

  1 minute

• fiberoptic view in lateral position

  1 minute

Study Arms (1)

study group

EXPERIMENTAL

after induction of general anesthesia, a proper size of Igel will be inserted after compelete muscle relaxation. In order to confirm proper positioning of the I-gel,a fiberoptic bronchoscope will be pass through the device and pushed forward up to1 cm proximal to it to obtain a glottic view, leak airway pressure test will be done. Afterwards the same patient will be placed in the lateral decubitus position ,confirmation of I-gel position using fiberoptic bronchoscope will be done and recorded.The leak air way pressure test will be done as previously done in supine position and recorded. The patient will be returned to supine position.

Device: I-gel supraglottic airway device

Interventions

I-gel supraglottic airway device DEVICE

After induction of general anesthesia, we will measure the Oropharyngeal leak airway pressure during controlled ventilation in supine and in positions after insertion of I-gel.

study group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI: ≥30 - \<40. Surgery: short time procedures \>60 minutes and ≤. 120 minutes

You may not qualify if:

• Patientswith neck or upper airway pathologies or other contraindications to supraglottic decives.
• Patients at risk of stomach contents regurge e.g. pregnant ,GIT Ulcer, Symptomatic reflux disease or Hiatus hernia ...etc Patients with risk of pulmonary aspiration e.g. Full stomach or incompetent gastro-oesophageal sphincter.
• History of gastric band or gastric bypass surgeries. Pregnant females. Laparotomy or laparoscopic procedures. Obstructive sleep apnea Patients with risk of bleeding.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, 11562, Egypt

Location

Related Publications (3)

• Bamgbade OA, Macnab WR, Khalaf WM. Evaluation of the i-gel airway in 300 patients. Eur J Anaesthesiol. 2008 Oct;25(10):865-6. doi: 10.1017/S0265021508004511. Epub 2008 Jun 6. No abstract available.

  PMID: 18534042 BACKGROUND

• Sanuki T, Uda R, Sugioka S, Daigo E, Son H, Akatsuka M, Kotani J. The influence of head and neck position on ventilation with the i-gel airway in paralysed, anaesthetised patients. Eur J Anaesthesiol. 2011 Aug;28(8):597-9. doi: 10.1097/EJA.0b013e32834698f4.

  PMID: 21505345 BACKGROUND

• Saracoglu KT, Demir A, Pehlivan G, Saracoglu A, Eti Z. Analysing the efficacy of the I-gel supraglottic airway device in the supine and lateral decubitus positions. Anaesthesiol Intensive Ther. 2018;50(4):259-262. doi: 10.5603/AIT.a2018.0028. Epub 2018 Sep 17.

  PMID: 30221337 BACKGROUND

MeSH Terms

Conditions

Obesity; Ige Responsiveness, Atopic

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bassant abdelhamid, M.D.

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: August 3, 2019
• First Posted: October 8, 2019
• Study Start: August 5, 2019
• Primary Completion: December 30, 2019
• Study Completion: January 15, 2020
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

EG (1)