Nasotracheal Intubation Using Shikani Optical Stylet (SOS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ru-Ping Dai, Central South University
ClinicalTrials.gov Identifier:
NCT00963677
First received: August 19, 2009
Last updated: May 1, 2012
Last verified: March 2012
Results First Received: May 26, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Intubation; Difficult
Intervention: Procedure: Nasotracheal Intubation through seeing optical stylet (SOS)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Intubation Without Difficulty     Difficult Intubation  
STARTED     35 [1]   20 [2]
COMPLETED     35     18 [3]
NOT COMPLETED     0     2  
[1] Patients without predicted difficult intubation
[2] Patients with predicted difficult intubation but not ventilation
[3] Two patients were excluded from the study due to the difficult ventilation with facemask ventilation



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    Intubation Without Difficulty     Difficult Intubation     Total  
Number of Participants  
[units: participants]
  35     20     55  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     35     20     55  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  34.2  ± 6.7     32.7  ± 6.3     33.4  ± 7.1  
Gender  
[units: participants]
     
Female     15     9     24  
Male     20     11     31  
Region of Enrollment  
[units: participants]
     
China     35     20     55  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of the Patients With Successful Nasotracheal Intubation   [ Time Frame: 1 hour(peri-intubation time) ]

2.  Secondary:   Time for Nasotracheal Intubation With the Use of Shikani Optical Stylet   [ Time Frame: 1 hour (peri-intubation time) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ru-Ping Dai, B.Sc(Med), PhD, Associate Professor
Organization: The Second Xiangya Hospital of Central South University
phone: 86-731-85295970
e-mail: Ruping_dai@yahoo.com.cn


No publications provided


Responsible Party: Ru-Ping Dai, Central South University
ClinicalTrials.gov Identifier: NCT00963677     History of Changes
Other Study ID Numbers: NSFC-30700790, RDai-CSU
Study First Received: August 19, 2009
Results First Received: May 26, 2010
Last Updated: May 1, 2012
Health Authority: China: National Natural Science Foundation