Application of Visual Laryngeal Mask Airway Combined With Endotracheal Intubation in General Anesthesia
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| ClinicalTrials.gov Identifier: NCT04719767 |
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Recruitment Status :
Not yet recruiting
First Posted : January 22, 2021
Last Update Posted : January 25, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| General Anesthesia Laryngeal Mask Endotracheal Intubation Surgery | Device: visual laryngeal mask | Not Applicable |
After entering the operating room, the patient received routine general anaesthesia monitoring, and anesthesia induction was conducted after three-party verification. Propofol (plasma target-controlled concentration: 3.5ug/ mL), midazolam (0.05mg/kg), fentanyl (2ug/kg) and rocuronium (0.6mg/kg) were used to induce the drugs.
After anesthesia induction, visual laryngeal mask airway was placed in the visual group and endotracheal intubation was guided under visual conditions. In the non-visual group, after judging the position of laryngeal mask by clinical experience, endotracheal intubation was inserted blindly. Selection of laryngeal mask airway (LMA) model based on: the ideal body weight of the patient, 3 was selected for the body weight of 30-50kg, 4 for the body weight of 50-70kg and 5 for the body weight > 70kg. The endotracheal tube intubation time, intubation times and intubation success rate of the two groups were recorded.
During the operation, propofol and fentanyl are used for anesthesia maintenance, and the anesthesiologist adjusts the anesthesia depth according to his/her own experience. Ten minutes before the end of the operation, endotracheal intubation was removed and the laryngeal mask airway was retained. The displacement rate of the laryngeal mask airway, the volume of secretion in airway and the incidence of laryngeal spasm were compared between the two groups.
After the surgery, the residual muscle relaxation was antagonized, and the laryngeal mask was removed after the patient regained consciousness and reached the extubation criteria. The hemodynamic parameters and the severity of cough during laryngeal mask airway removal were recorded. The incidence and severity of oropharyngeal pain, oropharyngeal numbness, hoarseness, nausea, and vomiting were assessed immediately after the patient woke up and was followed up before leaving the recovery room and on the first day after surgery.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Masking Description: | The patients, surgeons and the ones who collect data will be masked. |
| Primary Purpose: | Treatment |
| Official Title: | Application of Visual Laryngeal Mask Airway Combined With Endotracheal Intubation in Non-head and Neck Surgery Under General Anesthesia |
| Estimated Study Start Date : | February 1, 2021 |
| Estimated Primary Completion Date : | June 1, 2022 |
| Estimated Study Completion Date : | June 30, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: visual
In the visual group, a visual laryngeal mask was placed and endotracheal intubation was guided under visual conditions. The endotracheal tube was removed 10 minutes before the end of the operation, and the laryngeal mask was retained.
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Device: visual laryngeal mask
After anesthesia induction, visual laryngeal mask airway was placed in the visual group and tracheal intubation was guided under visual conditions. In the non-visual group, laryngeal mask airway was inserted, after clinical judgment of good counterpoint of the laryngeal mask, endotracheal intubation was inserted blindly through LMA. Selection of laryngeal mask airway (LMA) model: the ideal body weight of the patient was calculated. |
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No Intervention: Non-visual
In the non-visual group, laryngeal mask airway was inserted. After clinical judgment of good counterpoint, endotracheal intubation was inserted blindly through LMA. Endotracheal intubation was removed 10 minutes before the end of the operation, and the laryngeal mask airway was retained.
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- Intubation time (second) [ Time Frame: intraoperative ]Compare the time of endotracheal intubation through laryngeal mask airway under visual and non-visual conditions
- Success rate of the endotracheal intubation (%) [ Time Frame: intraoperative ]Compare success rate of endotracheal intubation through laryngeal mask airway under visual and non-visual conditions
- Displacement rate of the laryngeal mask airway (%) [ Time Frame: Immediately after operation ]Compare displacement rate of the laryngeal mask airway after tracheal intubation removal under visual and non-visual conditions
- Incidence of oropharyngeal pain as assessed by the VAS [ Time Frame: postoperative one day ]On the first day after operation, the patients were asked to score the oropharyngeal pain. Based on the distribution of pain VAS scores in postsurgical patients, the following cut points on the pain VAS have been recommended. No pain (0 -4 mm) Mild pain (5-44 mm) Moderate pain (45-74 mm) Severe pain (75-100 mm) The significance of the Visual Analog Scale.
- Incidence and severity of hoarseness as assessed by a numerical scale [ Time Frame: postoperative one day ]Normal = 1, weakened or hoarse = 2, unable to pronounce = 3
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Aged 18-70
- American Society of Anesthesiologist physical status (ASA) Ⅰ-II
- Undergoing non-head and neck surgery under general anesthesia with endotracheal intubation
- Sign the informed consent voluntarily;
Exclusion Criteria:
- Not willing to participate in the study or not able to sign the informed consent
- American Society of Anesthesiologist physical status (ASA) Ⅲ-Ⅳ
- Weight <30kg or BMI>40 kg/m2
- High risk of reflux aspiration
- Combined with severe respiratory disease
- Combined oropharyngeal lesions affect the laryngeal mask insertion
- Oropharyngeal pain in the last two weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04719767
| Contact: Yahong Gong, M.D. | 86-13611273163 | yh2087@163.com | |
| Contact: Xia Ruan, M.D. | 86-13691512741 | sheyaruan@sina.com |
| Study Director: | Yuguang Huang, M.D. | Peking Union Medical College Hospital |
Documents provided by Xia Ruan, Peking Union Medical College Hospital:
| Responsible Party: | Xia Ruan, Attending doctor of the Department of Anesthesiology, Peking Union Medical College Hospital |
| ClinicalTrials.gov Identifier: | NCT04719767 |
| Other Study ID Numbers: |
PUMCH-rx |
| First Posted: | January 22, 2021 Key Record Dates |
| Last Update Posted: | January 25, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |