Intervention: Device: I-gel supraglottic airway device
Sponsor: Cairo University
Recruiting
Hide glossaryGlossary
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms
x
Accepts healthy volunteers
Active comparator arm
Adverse event
Age or age group
All-cause mortality
Allocation
Arm
Arm type
Baseline characteristics
Canceled submission
Certain agreements
Certification
Certification/extension first posted
Certification/extension first submitted
Certification/extension first submitted that met QC criteria
City and distance
Clinical study
Clinical trial
ClinicalTrials.gov identifier (NCT number)
Collaborator
Condition/disease
Contact
Country
Cross-over assignment
Data Monitoring Committee (DMC)
Early Phase 1 (formerly listed as Phase 0)
Eligibility criteria
Enrollment
Exclusion criteria
Expanded access
Expanded access status
Expanded access type
Experimental arm
Extension request
Factorial assignment
First posted
First submitted
First submitted that met QC criteria
Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801)
Funder type
Gender-based eligibility
Group/cohort
Human subjects protection review board
Inclusion criteria
Informed consent
Informed consent form (ICF)
Intervention model
Intervention/treatment
Interventional study (clinical trial)
Investigator
Last update posted
Last update submitted
Last update submitted that met QC criteria
Last verified
Listed location countries
Location terms
Masking
NCT number
No intervention arm
Observational study
Observational study model
Other adverse event
Other study IDs
Other terms
Outcome measure
Parallel assignment
Participant flow
Patient registry
Phase
Phase 1
Phase 2
Phase 3
Phase 4
Phase Not Applicable
Placebo
Placebo comparator arm
Primary completion date
Primary outcome measure
Primary purpose
Principal investigator (PI)
Protocol
Quality control (QC) review
Randomized allocation
Recruitment status
Registration
Removed location countries
Reporting group
Responsible party
Results database
Results delayed
Results first posted
Results first submitted
Results first submitted that met QC criteria
Results returned after quality control review
Results submitted to ClinicalTrials.gov
Secondary outcome measure
Serious adverse event
Sex
Sham comparator arm
Single group assignment
Sort studies by
Sponsor
State
Statistical analysis plan (SAP)
Status
Study completion date
Study design
Study documents
Study IDs
Study record
Study registry
Study results
Study start date
Study type
Submitted date
Title
Title acronym
U.S. Agency for Healthcare Research and Quality (AHRQ)
U.S. Food and Drug Administration (FDA)
Unknown
Skip to Main Content
ClinicalTrials.gov
Find StudiesFind Studies Menu
About StudiesAbout Studies Menu
Submit StudiesSubmit Studies Menu
ResourcesResources Menu
About SiteAbout Site Menu
HomeSearch ResultsStudy Record Detail Save this study
Efficiency of I-gel Supraglottic Airway Device in Supine and Lateral Decubitus Position in Obese Patient
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04119245
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
See Contacts and Locations
Sponsor:
Cairo University
Information provided by (Responsible Party):
Bassant M. Abdelhamid, Cairo University
Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record
Study Description
Go to sections
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.
Condition or disease Intervention/treatment Phase
Obesity, Airway
Device: I-gel supraglottic airway device
Not Applicable
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
Study Design
Go to sections
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : August 5, 2019
Estimated Primary Completion Date : November 5, 2019
Estimated Study Completion Date : November 30, 2019
Resource links provided by the National Library of Medicine
MedlinePlus related topics: Pressure Sores
U.S. FDA Resources
Arms and Interventions
Go to sections
Arm Intervention/treatment
Experimental: study group
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
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.
Outcome Measures
Go to sections
Primary Outcome Measures :
supine Oropharyngeal leak airway pressure [ Time Frame: 1 minute ]
Oropharyngeal leak airway pressure during controlled ventilation in supine position after insertion of I-gel by one minute.
Secondary Outcome Measures :
lateral Oropharyngeal leak airway pressure [ Time Frame: 1 minute ]
Measure the Oropharyngeal leak airway pressure during controlled ventilation in lateral position after one minute from setting patient in lateral postion.
Time of insertion [ Time Frame: 3 minutes ]
Time of insertion which is defined as from picking up of the I-gel airway device until the presence of a square wave pattern on the capnograph and Number of insertion attempts.
• Fibro-optic view.The position of the mask is determined by pushing the fibro-optic to a maximum of 1cm over the I gel.
Swallowing [ Time Frame: 5 hours ]
The presence of swallowing difficulties, are questioned preoperatively and 5H postoperatively.
Hoarseness [ Time Frame: 5 hours ]
The presence of Hoarseness is questioned preoperatively and 5H postoperatively.
Nausea and vomiting [ Time Frame: 5 hours ]
The presence of nausea and vomiting are questioned preoperatively and 5H postoperatively.
Eligibility Criteria
Go to sections
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: 18 Years to 60 Years (Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Contacts and Locations
Go to sections
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119245
Contacts
Contact: Bassant M. abdelhamid, M.D. 01224254012 bassantmohamed197@yahoo.com
Contact: Inas Farouk, M.D. +201001587333 inasfarouk@hotmail.com
Locations
Egypt
Cairo university Recruiting
Cairo, Egypt, 11562
Contact: Bassant M. Abdelhamid, M. D. 01224254012 ext 002 Bassantmohamed197@yahoo.com
Contact: Inas Farouk, M. D. inasfarouk@hotmail.com
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Bassant abdelhamid, M.D. Cairo University
More Information
Go to sections
Publications:
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.
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.
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.
Responsible Party: Bassant M. Abdelhamid, associate professor, Cairo University
ClinicalTrials.gov Identifier: NCT04119245 History of Changes
Other Study ID Numbers: S-12-2019
First Posted: October 8, 2019 Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bassant M. Abdelhamid, Cairo University:
obesity
Igel
suraglotic device
Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
TO TOP
For Patients and Families For Researchers For Study Record Managers
HOME RSS FEEDS SITE MAP TERMS AND CONDITIONS DISCLAIMER CUSTOMER SUPPORT
Copyright Privacy Accessibility Viewers and Players Freedom of Information Act USA.gov
U.S. National Library of Medicine U.S. National Institutes of Health U.S. Department of Health and Human Services
Δεν υπάρχουν σχόλια:
Δημοσίευση σχολίου