AnesthesiaNCT03343496
Simplification and Implementation of Awake Fibreoptic Orotracheal Intubation
An observational study of Anesthesia and Trachea, run by Fudan University at 1 site in China.
Trial summary
Awake fibreoptic intubation (AFOI) is a classic and standard method for some special patients which is also difficult for anesthesiologists to learn and master. The procedure is sometimes hard and often takes about 20-30 min. Most of patients have a strong sense of discomfort. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia, Trachea, Intubation
- What is being tested?
- Awake fiberoptic intubation (AFOI)
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2017to 30 Jan 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The trial will be performed at Zhongshan Hospital, Fudan University in Shanghai, China.
Who may be able to join
- American Society of Anesthesiologists' physical status I-II patients
- Aged 18-75 years
- Mallampati Grade I-II
- Body Mass Index 18.5-28 kg·m-2
Who cannot join
- Allergic to the drugs involved in the study
- Neck mass or infection
- Drug or alcohol abuse
- Pregnant
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Awake fibreoptic intubation (AFOI) is a classic and standard method for some special patients which is also difficult for anesthesiologists to learn and master. The procedure is sometimes hard and often takes about 20-30 min. Most of patients have a strong sense of discomfort. Investigators conducted the research to study the simplification and feasibility of AFOI.
Read the detailed description
Many studies have studied the sedative drugs and regional anesthesia related to awake intubation. However, several problems of AFOI are existing including long operation time, patients' strong discomfort, coughing and resistance. And, to investigators' knowledge, there was a lack of a fixed procedure for the implementation of AFOI. Investigators conducted the research and aimed to study the simplification and feasibility of a new AFOI method based on years of clinical theory, practice and experience.
- Conditions
- Anesthesia, Trachea, Intubation
- Being tested
- Awake fiberoptic intubation (AFOI)
- Keywords
- Awake fiberoptic intubation
- Medical subject headings
- Tracheal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awake fiberoptic intubation (AFOI)Procedure or surgery
With forty patients (ASA I~II, aged 18~75, simulating cervical instability injury) recruited to be operated on under general anesthesia, two experienced anesthesiologists performed the whole procedures within the study. Pre anesthetic interview was taken to illustrate the procedures of tracheal intubation to the patients. The simplified method consisted of three parts: conscious sedation, regional anesthesia and intubation. The time of AFOI, rate of one-time intubation success, hemodynamic parameters, pulse oxygen saturation (SpO2), rate of amnesia of the intubation, patients' satisfaction, and relative complications were recorded accordingly.
What is being measured
The primary outcome is the main question the study is designed to answer.
The average total time of Awake Fiberoptic Orotracheal Intubation (AFOI)
The time from the midazolam injection to positive end tidal CO2 acquired (Minutes)
Measured: End of the AFOI
The rate of one-time intubation success.
All steps are successful once (Percentage)
Measured: End of the AFOI
Secondary outcomes (10)
Systolic blood pressure, SBP (mmHg)
SBP is used to assess hemodynamic fluctuations
Measured: During the AFOI
Diastolic blood pressure, DBP (mmHg)
DBP is used to assess hemodynamic fluctuations
Measured: During the AFOI
Heart rate, HR (bpm)
HR is used to assess hemodynamic fluctuations
Measured: During the AFOI
Rate of amnesia of the intubation
It is used to assess anterograde amnesia of midazolam
Measured: On the first postoperative day
Ramsay sedation scale
1= anxious or restless or both, 2 = cooperative, orientated and tranquil, 3 = responding to commands, 4 = brisk response to stimulus, 5 = sluggish response to stimulus, 6= No response to stimulus
Measured: During the AFOI
Patients' satisfaction
1 = excellent, 2 = good, 3 = fair, 4 = poor
Measured: On the first postoperative day
Unexpected coughing
Unexpected coughing was evaluated with 4 score (1=none, 2< 3 times unexpected slight coughing comparable to 'clearing ones' throat', 3≥2 times, mild unexpected coughing lasting less than a minute, 4=persistent unexpected coughing)
Measured: During the AFOI
Relative complications
Such as arrhythmias, bleeding or sore throat
Measured: End of the surgery and the first postoperative day
Vocal cord movement
1 = open, 2 = moving, 3 = closing, 4 = closed
Measured: During the AFOI
Hypoxic episode
SpO2<90%
Measured: During the AFOI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start17 Nov 2017
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengjin Ge,MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343496
- Sponsor's protocol ID
- B2017-112R
- Status last verified
- Jan 2019
- First submitted
- 11 Nov 2017
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplification and Implementation of Awake Fibreoptic Orotracheal Intubation
- ClinicalTrials.gov ID
- NCT03343496
- Acronym / sponsor ID
- B2017-112R
- Conditions
- Anesthesia, Trachea, Intubation
- Keywords
- Awake fiberoptic intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 17 Nov 2017 (actual)
- 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.
Awake fibreoptic intubation (AFOI) is a classic and standard method for some special patients which is also difficult for anesthesiologists to learn and master. The procedure is sometimes hard and often takes about 20-30 min. Most of patients have a strong sense of discomfort. Investigators conducted the research to study the simplification and feasibility of AFOI.
Detailed description
Many studies have studied the sedative drugs and regional anesthesia related to awake intubation. However, several problems of AFOI are existing including long operation time, patients' strong discomfort, coughing and resistance. And, to investigators' knowledge, there was a lack of a fixed procedure for the implementation of AFOI. Investigators conducted the research and aimed to study the simplification and feasibility of a new AFOI method based on years of clinical theory, practice and experience.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The trial will be performed at Zhongshan Hospital, Fudan University in Shanghai, China.
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists' physical status I-II patients
- Aged 18-75 years
- Mallampati Grade I-II
- Body Mass Index 18.5-28 kg·m-2
Key exclusion criteria (4 listed)
- Allergic to the drugs involved in the study
- Neck mass or infection
- Drug or alcohol abuse
- Pregnant
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 |
|---|---|---|
| Awake fiberoptic intubation (AFOI)With forty patients (ASA I~II, aged 18~75, simulating cervical instability injury) recruited to be operated on under general anesthesia, two experienced anesthesiologists performed the whole procedures within the study. Pre anesthetic interview was taken to illustrate the procedures of tracheal intubation to the patients. The simplified method consisted of three parts: conscious sedation, regional anesthesia and intubation. The time of AFOI, rate of one-time intubation success, hemodynamic parameters, pulse oxygen saturation (SpO2), rate of amnesia of the intubation, patients' satisfaction, and relative complications were recorded accordingly. | Procedure or surgery | – |
Primary outcome
The average total time of Awake Fiberoptic Orotracheal Intubation (AFOI)
Time frame: End of the AFOI
The time from the midazolam injection to positive end tidal CO2 acquired (Minutes)
The rate of one-time intubation success.
Time frame: End of the AFOI
All steps are successful once (Percentage)
10 secondary outcomes
Systolic blood pressure, SBP (mmHg)
Time frame: During the AFOI
Diastolic blood pressure, DBP (mmHg)
Time frame: During the AFOI
Heart rate, HR (bpm)
Time frame: During the AFOI
Rate of amnesia of the intubation
Time frame: On the first postoperative day
Ramsay sedation scale
Time frame: During the AFOI
Patients' satisfaction
Time frame: On the first postoperative day
Unexpected coughing
Time frame: During the AFOI
Relative complications
Time frame: End of the surgery and the first postoperative day
Vocal cord movement
Time frame: During the AFOI
Hypoxic episode
Time frame: During the AFOI
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 25 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Trachea, run by Fudan 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 4 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 25 Jan 2019. 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?
The average total time of Awake Fiberoptic Orotracheal Intubation (AFOI) (time frame: End of the AFOI). The study lists 2 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 25 Jan 2019.