Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-02-20 @ 6:40 PM
Study NCT ID:
NCT03173651
Status:
COMPLETED
Last Update Posted:
2017-06-02
First Post:
2017-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficiency of Different Oropharyngeal Airways as a Conduit for Fiberoptic Intubation. Comparative Study
Sponsor:
Kasr El Aini Hospital
Organization:
Study Overview
Official Title:
The Efficiency of Different Oropharyngeal Airways as a Conduit for Fiberoptic Intubation. Comparative Study
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
60 Patients were randomly allocated into three equal groups, after induction of general anesthesia one of the three airways included in the study (Modified Williams, Modified Gudle's and LMA MADgic airway) was used as a conduit for endotracheal tube placement using fiberoptic bronchoscopy. Airway insertion time, ease of insertion, adaptation to oral cavity and intubation time was recorded.
Detailed Description:
The study was conducted in Kasr Alainy hospital, faculty of medicine, Cairo University.
After approval of ethical committee and informed written consent from each patient, 60 patient aging above 18 years, ASA I-II , with Ganzouri airway score \<4 and undergoing elective surgeries under general anesthesia were included in the study.
Patients were randomly allocated into three equal groups:
Group M (GM) (n=20 patients): patient was intubated using LMA MADgic airway. Group W (GW) (n=20 patients): patient was intubated using modified Williams airway.
Group G (GG) (n=20 patients): patient was intubated using modified Guedel's airway.
Randomization was performed by random computer allocation with numbered closed opaque envelopes.
The study was performed by expert anesthesiologist in FOB intubation. In the preparation room, all patients was cannulated with a 20 gauge venous cannula and 0.02mg/kg Midazolam was given. Patient transferred to the operating room and was monitored with non-invasive blood pressure, pulse oximetry and ECG. After preoxygenation using a facemask for 5 min, induction of anesthesia was done with 2mg/kg propofol, 1 μg/kg of fentanyl and 0.6 mg/kg of atracurium.
After loss of consciousness the selected airway according to group randomization was inserted into the mouth (size selection and technique of insertion according to manufacturer instruction). Time of insertion defined as the time, in seconds, from touching the patients' mouth with the airway until capnographic confirmation of ventilation by facemask. The ease of insertion was determined by number of attempts of airway insertion. Adaptation of the airway was determined by adequacy of ventilation, fitness to the oral cavity and appearance of successive ETco2 waves.
Manual positive-pressure ventilation was then started with 100% oxygen and 1-1.5% isoflurane through the facemask for 3 min until complete muscle relaxation was confirmed (when train-of-four count becomes zero).
Loaded FOB was inserted for intubation through the airway, laryngeal view grade was recorded (LVG) using Brimacomb and Berry scale; thereafter, the fiberscope was advanced into the trachea to a level just above the carina and the tracheal tube was railroaded over it.
Tracheal intubation could be facilitated by tube rotation, jaw thrust, neck extension or flexion and adjustment of the airway was allawed and was recorded. The intubation time was recorded ; that is, the time from cessation of manual ventilation using a facemask until restarting of ventilation through the tracheal tube.
The airway was removed except the LMA MADgic airway which was removed before ETT insertion. The ease of airway removal was evaluated by the anesthesiologist.
After approval of ethical committee and informed written consent from each patient, 60 patient aging above 18 years, ASA I-II , with Ganzouri airway score \<4 and undergoing elective surgeries under general anesthesia were included in the study.
Patients were randomly allocated into three equal groups:
Group M (GM) (n=20 patients): patient was intubated using LMA MADgic airway. Group W (GW) (n=20 patients): patient was intubated using modified Williams airway.
Group G (GG) (n=20 patients): patient was intubated using modified Guedel's airway.
Randomization was performed by random computer allocation with numbered closed opaque envelopes.
The study was performed by expert anesthesiologist in FOB intubation. In the preparation room, all patients was cannulated with a 20 gauge venous cannula and 0.02mg/kg Midazolam was given. Patient transferred to the operating room and was monitored with non-invasive blood pressure, pulse oximetry and ECG. After preoxygenation using a facemask for 5 min, induction of anesthesia was done with 2mg/kg propofol, 1 μg/kg of fentanyl and 0.6 mg/kg of atracurium.
After loss of consciousness the selected airway according to group randomization was inserted into the mouth (size selection and technique of insertion according to manufacturer instruction). Time of insertion defined as the time, in seconds, from touching the patients' mouth with the airway until capnographic confirmation of ventilation by facemask. The ease of insertion was determined by number of attempts of airway insertion. Adaptation of the airway was determined by adequacy of ventilation, fitness to the oral cavity and appearance of successive ETco2 waves.
Manual positive-pressure ventilation was then started with 100% oxygen and 1-1.5% isoflurane through the facemask for 3 min until complete muscle relaxation was confirmed (when train-of-four count becomes zero).
Loaded FOB was inserted for intubation through the airway, laryngeal view grade was recorded (LVG) using Brimacomb and Berry scale; thereafter, the fiberscope was advanced into the trachea to a level just above the carina and the tracheal tube was railroaded over it.
Tracheal intubation could be facilitated by tube rotation, jaw thrust, neck extension or flexion and adjustment of the airway was allawed and was recorded. The intubation time was recorded ; that is, the time from cessation of manual ventilation using a facemask until restarting of ventilation through the tracheal tube.
The airway was removed except the LMA MADgic airway which was removed before ETT insertion. The ease of airway removal was evaluated by the anesthesiologist.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: