Comparing Hemodynamic Changes for Intubation With Shikani Intubating Stylet and Macintosh Laryngoscope

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sonia Vaida, Penn State University
ClinicalTrials.gov Identifier:
NCT01271543
First received: January 5, 2011
Last updated: November 12, 2013
Last verified: November 2013
Results First Received: January 31, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Anesthesia
Intervention: Device: Endotracheal Intubation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was performed at Penn State Milton S. Hershey Medical Center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No events

Reporting Groups
  Description
MacIntosh Group Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
Shikani Optical Stylet Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.

Participant Flow:   Overall Study
    MacIntosh Group     Shikani Optical Stylet  
STARTED     30     30  
COMPLETED     29     29  
NOT COMPLETED     1     1  



  Baseline Characteristics
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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.
Sample size of 30 patient for each group was calculated based on previous publications (2,3) to obtain of power of 80% and alfa of 0.05 to detect a 20 bpm for heart rate and 20 mmHg for blood pressure difference for paired hemodynamic data.

Reporting Groups
  Description
MacIntosh Group Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
Shikani Optical Stylet Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
Total Total of all reporting groups

Baseline Measures
    MacIntosh Group     Shikani Optical Stylet     Total  
Number of Participants  
[units: participants]
  30     30     60  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     29     29  
>=65 years     30     1     31  
Age  
[units: years]
Mean ± Standard Deviation
  39.1  ± 11     39.6  ± 13     39.5  ± 13  
Gender  
[units: participants]
     
Female     17     18     35  
Male     13     12     25  
Region of Enrollment  
[units: participants]
     
United States     30     30     60  



  Outcome Measures
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1.  Primary:   Heart Rate and Blood Pressure Double Product   [ Time Frame: Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. ]

2.  Secondary:   Time to Complete Laryngoscopy and Successful Intubation   [ Time Frame: Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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 adverse events


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


Results Point of Contact:  
Name/Title: Sonia Vaida
Organization: Penn State Milton S. Hershey Medical Center
phone: 7175318433
e-mail: svaida@hmc.psu.edu


No publications provided


Responsible Party: Sonia Vaida, Penn State University
ClinicalTrials.gov Identifier: NCT01271543     History of Changes
Other Study ID Numbers: IRB 35113, IRB protocol 35113
Study First Received: January 5, 2011
Results First Received: January 31, 2013
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board