An observational study in Anesthesia, Trachea and Intubation, sponsored by Fudan University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-01-25.
Sponsored by Fudan University · Observational
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.
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.
33 studies on the registry are indexed under Tracheal Diseases; 7 are open to participants now.
This study's enrollment of 40 is below the median of 288 across 10 observational studies indexed under Tracheal Diseases.
Browse Tracheal Diseases studies →Fudan University is the lead sponsor of 1,315 studies on the registry; 643 are open to participants now.
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The trial will be performed at Zhongshan Hospital, Fudan University in Shanghai, China.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
The average total time of Awake Fiberoptic Orotracheal Intubation (AFOI)
The time from the midazolam injection to positive end tidal CO2 acquired (Minutes)
Time frame: End of the AFOI
The rate of one-time intubation success.
All steps are successful once (Percentage)
Time frame: End of the AFOI
Systolic blood pressure, SBP (mmHg)
SBP is used to assess hemodynamic fluctuations
Time frame: During the AFOI
Diastolic blood pressure, DBP (mmHg)
DBP is used to assess hemodynamic fluctuations
Time frame: During the AFOI
Heart rate, HR (bpm)
HR is used to assess hemodynamic fluctuations
Time frame: During the AFOI
Rate of amnesia of the intubation
It is used to assess anterograde amnesia of midazolam
Time frame: 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
Time frame: During the AFOI
Patients' satisfaction
1 = excellent, 2 = good, 3 = fair, 4 = poor
Time frame: 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)
Time frame: During the AFOI
Relative complications
Such as arrhythmias, bleeding or sore throat
Time frame: End of the surgery and the first postoperative day
Vocal cord movement
1 = open, 2 = moving, 3 = closing, 4 = closed
Time frame: During the AFOI
Hypoxic episode
SpO2\<90%
Time frame: During the AFOI
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Jan 2018, 2 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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