Obesity, AirwayNCT04119245
Efficiency of I-gel Supraglottic Airway Device in Supine and Lateral Decubitus Position in Obese Patient
A study testing I-gel supraglottic airway device in people with Obesity, Airway, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Airway
- What is being tested?
- I-gel supraglottic airway device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2019to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI: ≥30 - <40. Surgery: short time procedures >60 minutes and ≤. 120 minutes
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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
- Conditions
- Obesity, Airway
- Being tested
- I-gel supraglottic airway device
- Keywords
- obesity, Igel, suraglotic device
- Medical subject headings
- Obesity, Ige Responsiveness, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-gel supraglottic airway deviceDevice
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 | Role | What they receive |
|---|---|---|
| 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. Receives: Device: I-gel supraglottic airway device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 minute
Secondary outcomes (6)
Swallowing
The presence of swallowing difficulties, are questioned preoperatively and 5H postoperatively.
Measured: 5 hours
Hoarseness
The presence of Hoarseness is questioned preoperatively and 5H postoperatively.
Measured: 5 hours
Nausea and vomiting
The presence of nausea and vomiting are questioned preoperatively and 5H postoperatively.
Measured: 5 hours
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.
Measured: 1 minute
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.
Measured: 1 minute
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.
Measured: 1 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start5 Aug 2019
- Primary completion30 Dec 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obesity, AirwayStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassant M. Abdelhamid, Cairo University
- Investigators
- Bassant abdelhamid, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119245
- Sponsor's protocol ID
- S-12-2019
- Status last verified
- Jan 2020
- First submitted
- 3 Aug 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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. No abstract available.
PubMed 18534042Sanuki 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.
PubMed 21505345Saracoglu 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.
PubMed 30221337
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04119245
- Acronym / sponsor ID
- S-12-2019
- Conditions
- Obesity, Airway
- Keywords
- obesity, Igel, suraglotic device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: I-gel supraglottic airway deviceafter 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI: ≥30 - <40. Surgery: short time procedures >60 minutes and ≤. 120 minutes
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-gel supraglottic airway deviceAfter 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. | Device | study group |
Primary outcome
comparison between supine and lateral 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 and n lateral position after one minute from setting patient in lateral postion.
6 secondary outcomes
Swallowing
Time frame: 5 hours
Hoarseness
Time frame: 5 hours
Nausea and vomiting
Time frame: 5 hours
fiberoptic view in supine position
Time frame: 1 minute
fiberoptic view in lateral position
Time frame: 1 minute
number of failed attempts of insertion
Time frame: 1 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Background: PubMed 18534042Bamgbade 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.
- Background: PubMed 21505345Sanuki 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.
- Background: PubMed 30221337Saracoglu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bassant abdelhamid, M.D. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-gel supraglottic airway device in people with Obesity, Airway, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison between supine and lateral Oropharyngeal leak airway pressure (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04119245, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.