- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01116999
Retrograde Light Target Tracheal Intubation Technique:Clinical Comparison With Direct Pharyngoscopic Tracheal Intubation
Clinical Comparison of Direct Pharyngoscopic Tracheal Intubation Technique With Light-guided Tracheal Intubation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The experiment was conducted under the close supervision of the coaching anesthesiologists in several stages.
The training stage: First of all, the operators received training with respect to the theories and principles of airway management, including techniques of bag-mask ventilation, Direct laryngoscopy and tracheal intubation and light-guided and tracheal intubation until they had a good master about the theoretical background, technical risks and indications of the two techniques. Then, they had to receive manikin training of the two techniques on the Airway Management Trainer. Exposure of the glottis(EG)/tracheal intubation(TI) training would be continued before they were able to use both techniques to complete three consecutive cases of Exposure of the glottis/tracheal intubation operation successfully on the manikin trainer within 120 seconds (s) at a time.
20 medical workers were assigned to perform TI within 120s with either Direct laryngoscopy TI or light-guided TI technique, which was selected randomly and then converted to the alternative one until they complete 5 cases with each of the two techniques. The time of EG started from mouth opening of the patient to the exposure of the glottis. The time of TI also started from mouth opening of the patient to the completion of inserting the tracheal guide to the tracheal and sealing it with cuff inflation. The EG time, Cormack-Lehane (C&L) grades, TI time, one-time success rate, and the overall success rate in using the two TI techniques were recorded.
The patient was laid in a supine position, with the head laid on a 7cm-high pillow for the sake of stability. The peripheral vein was accessed routinely and connected to a standard monitor for electrocardiography (ECG), SpO2 and noninvasive blood pressure (BP). Sufficient oxygen inhalation was initiated for > 3min before induction of general anesthesia with midazolam, propofol, fentanyl and rocuronium bromide. The anesthesiologist was not allowed to give any instruction and suggestion or assistance to the operator during the whole process. The coaching anesthesiologist supervised the whole TI process closely. Should any hidden risk occur or the TI exceed the required time of the experiment, the TI attempt of the operator would be terminated and replaced by the anesthesiologist in order to ensure patients' safety: TI exceeded 120s; Attempt of TI exceeded 2 times; SpO2 decreasing to below 95%; appearance of unstable hemodynamic situations (mean BP or HR fluctuating by more than 25% of the baseline value); or occurrence of airway injury as evidenced by stained blood on the Macintosh Blade. Any patient with C&L grade III~IV as discovered by the anesthesiologist during TI would be excluded from the present study and replaced by anther patient to re-start the experiment. A 7.0- or 7.5-mm-ID endotracheal tube was used as the guide according to the patient's condition.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200433
- Changhai Hospital affiliated to Second Military Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age range 18~55 years
- general anesthesia
- ASA I~II
- Mallampati Score grade I~II
- thyromental distance ≥6cm
- mouth-open ≥3cm
- body mass index (BMI) ≤30kg/m2
Exclusion Criteria:
- neck and maxillofacial surgeries
- temporomandibular joint (TMJ) disease
- potential risks for regurgitation and pulmonary aspiration
- in pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tracheal intubation
|
Tracheal intubation light guided technique.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ease to intubate (time and success rate required to perform intubation)
Time Frame: Within 8 months
|
Within 8 months
|
Collaborators and Investigators
Investigators
- Study Director: Tao Yang, MD, Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
- Study Director: Jiong Hou, MD, Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
- Study Director: Xiaoming Deng, Professor, Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
- Principal Investigator: Xu Zhang, MD, Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
- Principal Investigator: Wen Ni, MD, Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
- Principal Investigator: Xiaoyan Zhu, MD, Second Military Medical University
- Principal Investigator: Jinbao Li, MD, Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 19781007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tracheal Intubation Morbidity
-
Brno University HospitalCompletedTracheal Intubation MorbidityCzechia
-
IRCCS San RaffaeleUnknownTracheal Intubation MorbidityItaly
-
Tata Memorial HospitalCompletedTracheal Intubation MorbidityIndia
-
University of AlbertaKARL STORZ Endoscopy-America, Inc.; VerathonCompletedTracheal Intubation MorbidityCanada
-
Emory UniversityTerminatedAirway Morbidity | Intubation Complication | Anesthesia Intubation Complication | Tracheal Intubation Morbidity | Failed or Difficult Intubation, SequelaUnited States
-
University Hospital, LilleCompletedContinuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device (Nosten)Mechanical Ventilation Complication | Tracheal Intubation MorbidityFrance
-
Siriraj HospitalCompletedTracheal Intubation MorbidityThailand
-
University Hospital, LilleCompletedPain | Tracheal Intubation MorbidityFrance
-
Abant Izzet Baysal UniversityCompletedCardiovascular Diseases | Tracheal Intubation Morbidity | Lidocaine Causing Adverse Effects in Therapeutic UseTurkey
-
Ankara City Hospital BilkentCompletedChildren, Only | Tracheal Intubation Morbidity | Cuff | Airway EdemaTurkey
Clinical Trials on light guided tracheal intubation
-
Second Military Medical UniversityCompletedTransillumination-guided Fiberoptic Intubation IntubationChina
-
University of MalayaCompletedBed up Head Elevated Intubation PositionMalaysia
-
Konya Meram State HospitalNot yet recruiting
-
Mongi Slim HospitalCompletedPostoperative Pain | Anesthesia | Tracheal Intubation Morbidity | Sore-throatTunisia
-
University of Lausanne HospitalsCompletedNasal Obstruction | Lumbar Stenosis, FamilialSwitzerland
-
Patan Academy of Health SciencesNot yet recruitingTo Compare Success Rate of Video Laryngoscopy vs Direct Laryngoscopy
-
Mansoura UniversityCompletedTechniques of Endotracheal Intubation in PediatricsEgypt
-
Rigshospitalet, DenmarkAmbu A/SUnknownGeneral AnesthesiaDenmark, France
-
Suez Canal UniversityRecruiting
-
Yuzuncu Yıl UniversityCompleted