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
CRIS Registration Number |
KCT0005987 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Chonnam National University Hospital |
Organization Type | Medical Institute |
Project ID | CNUH-2021-052 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Chonnam National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
Not Applicable-Etc
General anesthesia Endotracheal intubation |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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