Tracheal Intubation MorbidityNCT01116999
Retrograde Light Target Tracheal Intubation Technique:Clinical Comparison With Direct Pharyngoscopic Tracheal Intubation
A study testing light guided tracheal intubation in people with Tracheal Intubation Morbidity, run by Second Military Medical University at 1 site in China.
Trial summary
The investigators hypothesise that, for novices, light guided tracheal intubation will improve the time and success rate of this clinical skill compared to standard direct tracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Tracheal Intubation Morbidity
- What is being tested?
- light guided tracheal intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- May 2010to Apr 2011
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- neck and maxillofacial surgeries
- temporomandibular joint (TMJ) disease
- potential risks for regurgitation and pulmonary aspiration
- in pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site
Changhai Hospital Affiliated to Second Military Medical University
Shanghai, Shanghai Municipality, 200433
About this study
Official title: Clinical Comparison of Direct Pharyngoscopic Tracheal Intubation Technique With Light-guided Tracheal Intubation
The investigators hypothesise that, for novices, light guided tracheal intubation will improve the time and success rate of this clinical skill compared to standard direct tracheal intubation.
Read the 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.
- Conditions
- Tracheal Intubation Morbidity
- Being tested
- light guided tracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
light guided tracheal intubationProcedure or surgery
Also called intubation
Tracheal intubation light guided technique.
| Study group | Role | What they receive |
|---|---|---|
| Tracheal intubation | Experimental | Not described Receives: Procedure: light guided tracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease to intubate (time and success rate required to perform intubation)
Measured: Within 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startMay 2010
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal Intubation MorbidityStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Tao, Second Military Medical University
- Investigators
- Tao Yang, MD, Study director, Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical UniversityJiong Hou, MD, Study director, Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical UniversityXiaoming Deng, Professor, Study director, Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical UniversityXu Zhang, MD, Principal investigator, Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical UniversityWen Ni, MD, Principal investigator, Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical UniversityXiaoyan Zhu, MD, Principal investigator, Second Military Medical UniversityJinbao Li, MD, Principal investigator, Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116999
- Sponsor's protocol ID
- 19781007
- Status last verified
- Sep 2011
- First submitted
- 4 May 2010
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Direct Pharyngoscopic Tracheal Intubation Technique With Light-guided Tracheal Intubation
- ClinicalTrials.gov ID
- NCT01116999
- Acronym / sponsor ID
- 19781007
- Conditions
- Tracheal Intubation Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Second Military Medical UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 5 May 2010 (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 investigators hypothesise that, for novices, light guided tracheal intubation will improve the time and success rate of this clinical skill compared to standard direct tracheal intubation.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tracheal intubation | Experimental | Procedure: light guided tracheal intubation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- age range 18~55 years
- general anesthesia
- ASA I~II
- Mallampati Score grade I~II
- thyromental distance ≥6cm
Key exclusion criteria (4 listed)
- neck and maxillofacial surgeries
- temporomandibular joint (TMJ) disease
- potential risks for regurgitation and pulmonary aspiration
- in pregnancy
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 |
|---|---|---|
| light guided tracheal intubationAlso: intubationTracheal intubation light guided technique. | Procedure or surgery | Tracheal intubation |
Primary outcome
Ease to intubate (time and success rate required to perform intubation)
Time frame: Within 8 months
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 27 Sep 2011.
Related trials for Tracheal Intubation Morbidity
Recruiting
Optimisation Strategy for Emergency Tracheal Intubation
Emergencies, Out-of-hospital Setting
Not yet recruitingPhase 2/3
Oral Melatonin VS Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients
Tracheal Intubation Morbidity, Laryngoscopy
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.
Tao Yang, MD study director
Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
Jiong Hou, MD study director
Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
Xiaoming Deng, Professor study director
Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical 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 light guided tracheal intubation in people with Tracheal Intubation Morbidity, run by Second Military Medical University at 1 site in China.
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 7 inclusion and 4 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 27 Sep 2011. 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 China. 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?
Ease to intubate (time and success rate required to perform intubation) (time frame: Within 8 months). 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 27 Sep 2011.