Trial Outcomes & Findings for Nasotracheal Intubation Using Shikani Optical Stylet (NCT NCT00963677)

Results Overview

After anesthesia induction, the patients were undergone nasotracheal intubation with SOS. Number for first time successful intubation was recorded. If the time for one attempt intubation exceeded more than 120 seconds, it would be regarded as failed intubation for this time intubation. If a patient could not be successfully intubated after three attempts, the patients would be viewed as a case failing nasotracheal intubation with SOS.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

55 participants

Primary outcome timeframe

1 hour(peri-intubation time)

Results posted on

2012-05-03

Participant Flow

Patients (ASA I-III) who required general anesthesia undergoing oral and maxillofacial surgery and agreed to participate in the present study were recruited from August 2009 to November 2009 in the Second Xiangya Hospital of Central South university. All the patients have signed the consented forms for the study.

55 patients were recruited into the study and assigned to two groups. The patients without predicted difficult intubation (n=35) were rectuited into Group A. The patients (n=20) with predicted intubation but not difficult ventilation were recruited into Group B. Two patients were excluded from the present study due to difficult ventilation.

Participant milestones

Participant milestones
Measure	Intubation Without Difficulty Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet	Difficult Intubation The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
Overall Study STARTED	35	20
Overall Study COMPLETED	35	18
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nasotracheal Intubation Using Shikani Optical Stylet

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intubation Without Difficulty n=35 Participants Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet	Difficult Intubation n=20 Participants The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.	Total n=55 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants	20 Participants n=7 Participants	55 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	34.2 years STANDARD_DEVIATION 6.7 • n=5 Participants	32.7 years STANDARD_DEVIATION 6.3 • n=7 Participants	33.4 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	9 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	11 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment China	35 participants n=5 Participants	20 participants n=7 Participants	55 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour(peri-intubation time)

After anesthesia induction, the patients were undergone nasotracheal intubation with SOS. Number for first time successful intubation was recorded. If the time for one attempt intubation exceeded more than 120 seconds, it would be regarded as failed intubation for this time intubation. If a patient could not be successfully intubated after three attempts, the patients would be viewed as a case failing nasotracheal intubation with SOS.

Outcome measures

Outcome measures
Measure	Difficult Intubation n=20 Participants The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.	Intubation Without Difficulty n=35 Participants Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
Number of the Patients With Successful Nasotracheal Intubation	18 participants	35 participants

SECONDARY outcome

Timeframe: 1 hour (peri-intubation time)

The time of nasotracheal intubation was calculated from the SOS insertion to withdrawing the stylet from the endotracheal tube.

Outcome measures

Outcome measures
Measure	Difficult Intubation n=20 Participants The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.	Intubation Without Difficulty n=35 Participants Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
Time for Nasotracheal Intubation With the Use of Shikani Optical Stylet	27.2 seconds Standard Deviation 8.1	26.3 seconds Standard Deviation 6.4

Adverse Events

Intubation Without Difficulty

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Difficult Intubation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ru-Ping Dai, B.Sc(Med), PhD, Associate Professor

The Second Xiangya Hospital of Central South University

Phone: 86-731-85295970

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place