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

Primary Purpose

Obesity, Airway

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
I-gel supraglottic airway device
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obesity, Airway focused on measuring obesity, Igel, suraglotic device

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

  • Cairo university

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

study group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Swallowing
The presence of swallowing difficulties, are questioned preoperatively and 5H postoperatively.
Hoarseness
The presence of Hoarseness is questioned preoperatively and 5H postoperatively.
Nausea and vomiting
The presence of nausea and vomiting are questioned preoperatively and 5H postoperatively.
fiberoptic view in supine position
4 points: only vocal cords can be seen, 3 points: vocal cords and posterior epiglottis can be seen, 2 points: vocal cords and anterior epiglottis can be seen, 1 Point: Vocal cords cannot be seen.
fiberoptic view in lateral position
4 points: only vocal cords can be seen, 3 points: vocal cords and posterior epiglottis can be seen, 2 points: vocal cords and anterior epiglottis can be seen, 1 Point: Vocal cords cannot be seen.
number of failed attempts of insertion
I-gel insertion was facilitated by head flexion or extension, or slightly pulling or pushing the device in case of insertion problem. If insertion or ventilation fails three times in succession, Endotracheal tube would immediately inserted and the patient was excluded from the study. The number of excluded cases were recorded.

Full Information

First Posted
August 3, 2019
Last Updated
January 19, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04119245
Brief Title
Efficiency of I-gel Supraglottic Airway Device in Supine and Lateral Decubitus Position in Obese Patient
Official Title
Evaluation of the Efficiency of I-gel Supraglottic Airway Device in Mechanical Ventilation in Supine and Lateral Decubitus Position in Obese Patient;Prospective Observational Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
prospective observational cohort study. Induction of anethesisa will be started after pre-oxygenating the patient for 3min , with administerating Propofol (2mg/kg)(lean body weight)), Fentanyl (2μg/kg) and Atracurium (0.5mg/kg)(based on ideal body weight.The patient will to be ventilated by a 100% oxygen and 1.2% isoflurane with fresh gas flow 6L/min for 5 min.immediately after induction heart rate , blood pressure and oxygen saturation will be recorded. A proper sized I-gel according to the patient's weight and manifacturer instructions (Intersurgical Ltd, UK) ( 4 or 5 adult sizeI-gel) will be lubricated with a water based lubricant from the front and back sides of the device, will be inserted after compelete muscle relaxation (Train of four = zero) In case of insertion problem various adjuvant manoeuvres will be used such as such as head flexion or extension, or slightly pulling or pushing the device. Any additional manoeuvres will be recorded. If insertion or ventilation fails three times in succession, Endotracheal tube will be immediately inserted and the patient will be excluded from the study. The number of excluded cases will be recorded The circut will be connected to the device,Capnograph will be attached and end tidal carbon dioxide will be recorded. The ventilator parameters will be set with tidal volume (4-6 ml/kg) at a respiratory rate(12-15 breath/min) to maintain ETCO2 from 30-35 mmHg. Anaethesia will be maintanied by a mixture of 50% oxygen and 50% medical air,Isoflurane 1.2% and Atracurium (0.01 mg/kg) will be given according to train of four . Analgesia of pethidine 100mg IV will be given as intraoperative analgesia. 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. Afterwards the same patient will be placed in the lateral decubitus position.Blood pressure,Heart rate ,Oxygen saturation and End tidal CO2 will be recorded immedialy. After confirming proper ventilation as before ,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 where a proper size Orogastric tube will be inserted.The surgery can be started and Heamodynamics and ventilation will be monitored. By the end of the surgery the patient will be reversed from general anaesthesia by administrating Neostigmine (0.04mg/kg) and Atropine (0.01mg/kg). intravenously at (TOF=3) and the I-gel will be removed at the end.The presence of blood on the I-gel device, or the occurrence of any complications, will be recorded. The patient will be transfered to the post operative care unit

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Airway
Keywords
obesity, Igel, suraglotic device

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
I-gel supraglottic airway device
Intervention Description
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.
Primary Outcome Measure Information:
Title
comparison between supine and lateral Oropharyngeal leak airway pressure
Description
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.
Time Frame
1 minute
Secondary Outcome Measure Information:
Title
Swallowing
Description
The presence of swallowing difficulties, are questioned preoperatively and 5H postoperatively.
Time Frame
5 hours
Title
Hoarseness
Description
The presence of Hoarseness is questioned preoperatively and 5H postoperatively.
Time Frame
5 hours
Title
Nausea and vomiting
Description
The presence of nausea and vomiting are questioned preoperatively and 5H postoperatively.
Time Frame
5 hours
Title
fiberoptic view in supine position
Description
4 points: only vocal cords can be seen, 3 points: vocal cords and posterior epiglottis can be seen, 2 points: vocal cords and anterior epiglottis can be seen, 1 Point: Vocal cords cannot be seen.
Time Frame
1 minute
Title
fiberoptic view in lateral position
Description
4 points: only vocal cords can be seen, 3 points: vocal cords and posterior epiglottis can be seen, 2 points: vocal cords and anterior epiglottis can be seen, 1 Point: Vocal cords cannot be seen.
Time Frame
1 minute
Title
number of failed attempts of insertion
Description
I-gel insertion was facilitated by head flexion or extension, or slightly pulling or pushing the device in case of insertion problem. If insertion or ventilation fails three times in succession, Endotracheal tube would immediately inserted and the patient was excluded from the study. The number of excluded cases were recorded.
Time Frame
1 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI: ≥30 - <40. Surgery: short time procedures >60 minutes and ≤. 120 minutes Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bassant abdelhamid, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo university
City
Cairo
ZIP/Postal Code
11562
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18534042
Citation
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.
Results Reference
background
PubMed Identifier
21505345
Citation
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.
Results Reference
background
PubMed Identifier
30221337
Citation
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.
Results Reference
background

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

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