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A comparative study of different height of operation table for tracheal intubation with videolaryngoscopy in ramped positioned patients

Status Approved

  • First Submitted Date

    2021/03/03

  • Registered Date

    2021/03/11

  • Last Updated Date

    2024/02/13

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005987
    Unique Protocol ID CNUH-2021-052
    Public/Brief Title A comparative study of different height of operation table for tracheal intubation with videolaryngoscopy in ramped positioned patients
    Scientific Title A comparative study of different height of operation table for tracheal intubation with videolaryngoscopy in ramped positioned patients
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number CNUH-2021-052
    Approval Date 2021-02-24
    Institutional Review Board Name Chonnam national university hospital institutional review board
    Institutional Review Board Address 42, Jebong-ro, Dong-gu, Gwangju
    Institutional Review Board Telephone 062-220-5257
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Jongmin Kim
    Title Assistant professor
    Telephone +82-62-220-6895
    Affiliation Chonnam National University Hospital
    Address 42 Jebong-ro, Dong-gu, Gwangju61469, South korea
    Contact Person for Public Queries
    Name Jongmin Kim
    Title Assistant professor
    Telephone +82-62-220-6895
    Affiliation Chonnam National University Hospital
    Address 42 Jebong-ro, Dong-gu, Gwangju61469, South korea
    Contact Person for Updating Information
    Name Jeongmin Kim
    Title Assistant professor
    Telephone +82-62-220-6895
    Affiliation Chonnam National University Hospital
    Address 42 Jebong-ro, Dong-gu, Gwangju61469, South korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2021-04-30 Actual
    Target Number of Participant 144
    Primary Completion Date 2021-12-31 , Actual
    Study Completion Date 2021-12-31 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Chonnam National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2021-04-30 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Chonnam National University Hospital
    Organization Type Medical Institute
    Project ID CNUH-2021-052
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Chonnam National University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    For successful endotracheal intubation, it is important to adjust the height of the patient and the distance between the operator to provide good visibility to the operator and to reduce fatigue. Research has shown that better glottal vision was secured when the patient's head was positioned at the operator's nipple level during endotracheal intubation using a conventional laryngoscope. 
     The head elevation laryngoscopy posture is an endotracheal intubation posture that facilitates exposure of the glottis, which aligns the external auditory and sternum with a horizontal line. This posture inevitably increases the position of the patient's head and affects the operator's movement. It is known that the use of a video laryngoscope, unlike conventional laryngoscopes, provides better glottal vision by delivering images of the glottis opening to the operator even if the patient's oral, pharyngeal, and laryngeal axes are not aligned.
    However, there have been few studies on the proper height of the patient's head for intubation using a video laryngoscope. We predicted that the intubation time would vary according to the height of the patient's head when intubation using a video laryngoscope in head elevation laryngoscopy posture. To prove this, an experiment was planned by dividing the patient's head height into the operator's nipple height group and umbilicus height group.
    
    Among the patients who meet the inclusion criteria, only patients who have given written consent to participate in this clinical trial are eligible. This study will proceed to record screening and preoperative information, and procedure-related information (mask ventilation and endotracheal intubation) after administration of general anesthetic agents.
    The patients are assigned to Group N or Group X according to a pre-set randomization table.
    The patients enter the operating room and places appropriate pillows and fabrics on the patient's upper body and behind the head so that the external ear canal and the sternal notch are in the horizontal line. In Group X, the height of the operating bed is adjusted so that the height of the patient's head is located in the practitioner's xiphoid process, and in Group N, the height of the operating bed is adjusted so that the height of the patient's head is located at the height of the practitioner's nipple.
    Subjects are preoxygenated with 100% oxygen for 3 minutes. Induce anesthesia by injecting propofol (1.5 – 2.0 mg/kg) and remifentanil (0.1 – 1.0 ㎍/kg/min). After loss of consciousness, a neuromuscular blocker is injected. For neuromuscular blockade, rocuronium 0.6-0.8 mg/kg is used.
    After neuromuscular blockade, the difficulty of mask ventilation was evaluated using the warters grading scale.
    The intubation tube is #7.0 for women and #8.0 for men, and the video laryngoscope is Covidien McGRATH® MAC with #3 blade, and the stylet is mounted on the intubation tube according to the shape of the blade.
    Glottal exposure is assessed using a cormack-lehane grade.
    The difficulty of tracheal intubation is evaluated using the intubation difficulty scale.
    The time required for tracheal intubation is divided into the laryngoscope operation time and the tube operation time and recorded. The laryngoscope operation time is from the time when the laryngoscope is handed over to the time when Cormack grade is confirmed, and the tube operation time is from the time when the tube is handed over to the time when endotracheal intubation is confirmed through the end-expiratory carbon dioxide monitoring device by connecting the tube and the respiratory circuit.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
     Supportive Care
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Subject
    Allocation RCT
    Intervention Type Others  
    Intervention Description
    places appropriate pillows and fabrics on the patient's upper body and behind the head so that the external ear canal and the sternal notch are in the horizontal line. In Group X, the height of the operating bed is adjusted so that the height of the patient's head is located in the practitioner's xiphoid process, and in Group N, the height of the operating bed is adjusted so that the height of the patient's head is located at the height of the practitioner's nipple.
    Number of Arms 2
    Arm 1

    Arm Label

    Group X

    Target Number of Participant

    72

    Arm Type

    Experimental

    Arm Description

    After placing an appropriate pillow and fabric on the upper body and the back of the patient's head so that the external ear canal and the tracheal dentition are in a straight line, adjust the height of the surgery bed so that the height of the patient's head is at the height of the operator's belly button, and before anesthesia with 100% oxygen for 3 minutes Do oxygenation. Induce anesthesia by injecting Propofol and Remifentanil. After loss of consciousness, a neuromuscular blocker is administered. For neuromuscular blockade, Rocuronium is used. To evaluate the difficulty of mask ventilation after neuromuscular blockade. The intubation tube is #7.0 for women and #8.0 for men, and a video laryngoscope is prepared with Covidien McGRATH® MAC with #3 Blade, and a stylet is mounted on the intubation tube according to the shape of the blade. Glottal exposure is assessed using Cormack-lehane Grade. The difficulty of tracheal intubation is evaluated using the intubation difficulty scale. The time required for tracheal intubation is divided into the laryngoscope operation time and the tube operation time and recorded. The laryngoscope operation time is from the time when the laryngoscope is handed over to the time when Cormack grade is confirmed, and the tube operation time is from the time when the tube is handed over to the time when endotracheal intubation is confirmed through the end-expiratory carbon dioxide monitoring device by connecting the tube and the respiratory circuit.
    Arm 2

    Arm Label

    Group N

    Target Number of Participant

    72

    Arm Type

    Active comparator

    Arm Description

    After placing an appropriate pillow and fabric on the upper body and the back of the patient's head so that the external ear canal and the tracheal dentition are in a straight line, adjust the height of the surgery bed so that the height of the patient's head is at the height of the operator's nipple, and before anesthesia with 100% oxygen for 3 minutes Do oxygenation. Induce anesthesia by injecting Propofol and Remifentanil. After loss of consciousness, a neuromuscular blocker is administered. For neuromuscular blockade, Rocuronium is used. To evaluate the difficulty of mask ventilation after neuromuscular blockade. The intubation tube is #7.0 for women and #8.0 for men, and a video laryngoscope is prepared with Covidien McGRATH® MAC with #3 Blade, and a stylet is mounted on the intubation tube according to the shape of the blade. Glottal exposure is assessed using Cormack-lehane Grade. The difficulty of tracheal intubation is evaluated using the intubation difficulty scale. The time required for tracheal intubation is divided into the laryngoscope operation time and the tube operation time and recorded. The laryngoscope operation time is from the time when the laryngoscope is handed over to the time when Cormack grade is confirmed, and the tube operation time is from the time when the tube is handed over to the time when endotracheal intubation is confirmed through the end-expiratory carbon dioxide monitoring device by connecting the tube and the respiratory circuit.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s)    Not Applicable-Etc 

    General anesthesia Endotracheal intubation
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~80Year

    Description

    Patients scheduled for elective surgery under general anesthesia
    patients who is American Society of Anesthesiology Physical status 1-3
    Exclusion Criteria
    Patients with body mass index over 30 kg/m2
    Patients predicted to need awake tracheal intubation
    Patients predicted to require nasotracheal intubation
    Patients with pathological aspects of the oropharynx
    Patients who need to limit cervical spine movement due to unstable cervical spine
    Patients judged unsuitable by other researchers
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    Time taken for tracheal intubation
    Timepoint
    The time required for endotracheal intubation is measured. The intubation time consists of the time to check the glottal entrance with a video laryngoscope and the time the tube passes through the glottal entrance.
    Secondary Outcome(s) 1
    Outcome
    The degree of exposure of the glottis
    Timepoint
    After lifting the epiglottis with a video laryngoscope
    Secondary Outcome(s) 2
    Outcome
    Difficulty in mask ventilation, Difficulty of intubation
    Timepoint
    Mask ventilation is performed after the administration of a neuromuscular blocker and then tracheal intubation is performed.
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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