An interventional study of I-gel LMA insertion and AuraGain LMA insertion in Respiratory Aspiration of Gastric Content, sponsored by Adiyaman University Research Hospital. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-05-09.
Sponsored by Adiyaman University Research Hospital · Not applicable, Interventional, and Other
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.
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.
28 studies on the registry are indexed under Respiratory Aspiration of Gastric Contents; 6 are open to participants now.
This study's enrollment of 114 is close to the median of 113 across 16 interventional studies indexed under Respiratory Aspiration of Gastric Contents.
Browse Respiratory Aspiration of Gastric Contents studies →Adiyaman University Research Hospital is the lead sponsor of 48 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
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.
Device: I-gel LMA insertion
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.
Device: AuraGain LMA insertion
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.
Device: ETT insertion
'I-gel LMA insertion' was done following anesthesia induction.
'AuraGain LMA insertion' was done following anesthesia induction.
'ETT insertion' was done following anesthesia induction.
Insertion time
It was assessed that how many secs it takes to insert the device
Time frame: Perioperative
Attempts to insertion
It was assessed that how many attempts needed to insert the device
Time frame: Perioperative
Airway related complications
Airway related complications like bronchospasm,gastric regurgitation,smooth tissue damages were assessed
Time frame: Perioperative
Heart Rate bpm
Heart rates changes were evaluated preoperative and after device insertion and then in every 5 mins.
Time frame: Perioperative
Systolic blood pressure mmHg
Systolic blood pressure changes were evaluate preoperative,following device insertion then in every 5 mins.
Time frame: Perioperative
Diastolic blood pressure mmHg
Diastolic blood pressures were evaluated preoperative,following device insertion then in every 5 mins.
Time frame: Perioperative
Peak airway pressure
During the surgery peak airway pressures were assessed following device insertion snd then in every 5 mins.
Time frame: Perioperative
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Respiratory Aspiration of Gastric Contents→
Adiyaman University Research Hospital