Respiratory Aspiration of Gastric ContentAILMALCNCT02925598
AuraGainTM and I-Gel® Laryngeal Masks in General Anesthesia for Laparoscopic Cholecystectomy
A study testing I-gel LMA insertion, AuraGain LMA insertion and ETT insertion in people with Respiratory Aspiration of Gastric Content, run by Adiyaman University Research Hospital.
Trial summary
The standard procedure used for airway control in general anesthesia for LC (laparoscopic cholecystectomy) is endotracheal intubation (EI). AuraGain and I-Gel are supraglottic airway devices (SADs) used for airway control for certain types of surgeries. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Aspiration of Gastric Content
- What is being tested?
- I-gel LMA insertion, AuraGain LMA insertion and ETT insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Apr 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (ASA) 1-2 physical status scheduled for elective LC
Who cannot join
- under the age of 18, history of hiatus hernia, gastroesophageal reflux, body mass index (BMI) > 30 kg m-2, ASA physical status 3 or over and patients who met the difficult intubation criteria
About this study
Official title: AuraGainTM and I-Gel® Laryngeal Masks in General Anesthesia for Laparoscopic Cholecystectomy - Performance Characteristics and Effects on Hemodynamics
The standard procedure used for airway control in general anesthesia for LC (laparoscopic cholecystectomy) is endotracheal intubation (EI). AuraGain and I-Gel are supraglottic airway devices (SADs) used for airway control for certain types of surgeries. The aim of this study was to evaluate and compare the performances of new types of SADs with EI regarding their insertion times, durations, perioperative complications and effects on hemodynamic parameters and peak airway pressures (Paw) in LC as well.
Read the detailed description
The standard procedure used for airway control in general anesthesia for LC (laparoscopic cholecystectomy) is endotracheal intubation (EI). AuraGain and I-Gel are supraglottic airway devices (SADs) used for airway control for certain types of surgeries.Previous studies have investigated and/or compared the performance of ProSeal™ LMA (Intavent Orthofix, Maidenhead, UK) during LC. But the performances of I-Gel and AuraGain have not been studied well yet. The main aim of this study was to evaluate and compare the performances of new types of SADs (i.e. AuraGain and I-Gel) with endotracheal intubation regarding their insertion times, ease of insertion and perioperative complications. The secondary aim was to observe their effects on hemodynamic parameters and peak airway pressures.
- Being tested
- I-gel LMA insertion, AuraGain LMA insertion, ETT insertion
- Keywords
- Laringeal masks, Cholecystectomy, Laparascopic, Intubation, intratracheal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-gel LMA insertionDevice
'I-gel LMA insertion' was done following anesthesia induction.
AuraGain LMA insertionDevice
'AuraGain LMA insertion' was done following anesthesia induction.
ETT insertionDevice
'ETT insertion' was done following anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| I-gel LMA | Experimental | I-gel LMA insertion: I-gel insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and EtCO2 waveform. Receives: Device: I-gel LMA insertion |
| AuraGain LMA | Experimental | AuraGain insertion:AuraGain LMA insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and EtCO2 waveform. Receives: Device: AuraGain LMA insertion |
| Endotracheal tube (ETT) | Experimental | Endotracheal tube insertion: Endotracheal tube (ETT) insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and EtCO2 waveform. Receives: Device: ETT insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insertion time
It was assessed that how many secs it takes to insert the device
Measured: Perioperative
Attempts to insertion
It was assessed that how many attempts needed to insert the device
Measured: Perioperative
Airway related complications
Airway related complications like bronchospasm,gastric regurgitation,smooth tissue damages were assessed
Measured: Perioperative
Secondary outcomes (4)
Heart Rate bpm
Heart rates changes were evaluated preoperative and after device insertion and then in every 5 mins.
Measured: Perioperative
Systolic blood pressure mmHg
Systolic blood pressure changes were evaluate preoperative,following device insertion then in every 5 mins.
Measured: Perioperative
Diastolic blood pressure mmHg
Diastolic blood pressures were evaluated preoperative,following device insertion then in every 5 mins.
Measured: Perioperative
Peak airway pressure
During the surgery peak airway pressures were assessed following device insertion snd then in every 5 mins.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startJan 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Aspiration of Gastric ContentStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ülkü Sabuncu, Adiyaman University Research Hospital
- Investigators
- Ulku Sabuncu, MD, Principal investigator, Adiyaman university Research and Educational Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925598
- Sponsor's protocol ID
- 2015/178
- Acronym
- AILMALC
- Status last verified
- May 2017
- First submitted
- 5 Sep 2016
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AuraGainTM and I-Gel® Laryngeal Masks in General Anesthesia for Laparoscopic Cholecystectomy - Performance Characteristics and Effects on Hemodynamics
- ClinicalTrials.gov ID
- NCT02925598
- Acronym / sponsor ID
- AILMALC / 2015/178
- Keywords
- Laringeal masks, Cholecystectomy, Laparascopic, Intubation, intratracheal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 Oct 2016 (estimated)
- 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.
The standard procedure used for airway control in general anesthesia for LC (laparoscopic cholecystectomy) is endotracheal intubation (EI). AuraGain and I-Gel are supraglottic airway devices (SADs) used for airway control for certain types of surgeries. The aim of this study was to evaluate and compare the performances of new types of SADs with EI regarding their insertion times, durations, perioperative complications and effects on hemodynamic parameters and peak airway pressures (Paw) in LC as well.
Detailed description
The standard procedure used for airway control in general anesthesia for LC (laparoscopic cholecystectomy) is endotracheal intubation (EI). AuraGain and I-Gel are supraglottic airway devices (SADs) used for airway control for certain types of surgeries.Previous studies have investigated and/or compared the performance of ProSeal™ LMA (Intavent Orthofix, Maidenhead, UK) during LC. But the performances of I-Gel and AuraGain have not been studied well yet. The main aim of this study was to evaluate and compare the performances of new types of SADs (i.e. AuraGain and I-Gel) with endotracheal intubation regarding their insertion times, ease of insertion and perioperative complications. The secondary aim was to observe their effects on hemodynamic parameters and peak airway pressures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I-gel LMA | Experimental | Device: I-gel LMA insertionI-gel LMA insertion: I-gel insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and EtCO2 waveform. |
| AuraGain LMA | Experimental | Device: AuraGain LMA insertionAuraGain insertion:AuraGain LMA insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and EtCO2 waveform. |
| Endotracheal tube (ETT) | Experimental | Device: ETT insertionEndotracheal tube insertion: Endotracheal tube (ETT) insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and EtCO2 waveform. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (ASA) 1-2 physical status scheduled for elective LC
Key exclusion criteria (1 listed)
- under the age of 18, history of hiatus hernia, gastroesophageal reflux, body mass index (BMI) > 30 kg m-2, ASA physical status 3 or over and patients who met the difficult intubation criteria
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 LMA insertion'I-gel LMA insertion' was done following anesthesia induction. | Device | I-gel LMA |
| AuraGain LMA insertion'AuraGain LMA insertion' was done following anesthesia induction. | Device | AuraGain LMA |
| ETT insertion'ETT insertion' was done following anesthesia induction. | Device | Endotracheal tube (ETT) |
Primary outcome
Insertion time
Time frame: Perioperative
It was assessed that how many secs it takes to insert the device
Attempts to insertion
Time frame: Perioperative
It was assessed that how many attempts needed to insert the device
Airway related complications
Time frame: Perioperative
Airway related complications like bronchospasm,gastric regurgitation,smooth tissue damages were assessed
4 secondary outcomes
Heart Rate bpm
Time frame: Perioperative
Systolic blood pressure mmHg
Time frame: Perioperative
Diastolic blood pressure mmHg
Time frame: Perioperative
Peak airway pressure
Time frame: Perioperative
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 9 May 2017.
- Individual participant dataSharing planned: No
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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.
Ulku Sabuncu, MD principal investigator
Adiyaman university Research and Educational Hospital
Questions about this trial
What is this clinical trial studying?
A study testing I-gel LMA insertion, AuraGain LMA insertion and ETT insertion in people with Respiratory Aspiration of Gastric Content, run by Adiyaman University Research Hospital.
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 1 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 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Insertion time (time frame: Perioperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2017.