Airway Morbidity, Anaesthesia
Conditions
Keywords
laryngeal mask Supreme, i-gel, laparoscopic gynecological surgery
Brief summary
To compare the effects of i-gel and Laryngeal mask airway Supreme (LMA-Supreme) on ventilation parameters and surgical view during Trendelenburg Position laparoscopic gynecological surgery in cases administered positive pressure ventilation without the use of neuromuscular agents.
Detailed description
Prospective, randomized and double-blind study, aged from 18 to 65 years undergoing elective laparoscopic gynecological surgery. The patients are randomly assigned to 2 groups: * Group 1: i-gel * Group 2: LMA- Supreme Procedure: The investigation protocol contains the following sections: 1. Induction of anaesthesia. For preoperative sedation 0.02 mg/kg midazolam IV will be administered. 2 minutes of 0.2 µ/kg/min remifentanil and 6 mg kg st-1 propofol infusion, IV 1-2 mg kg-1 propofol . No muscle relaxant will be used for insertion of the airway device. 2. Bispectral index values will be held between 40-60.Bispectral index values will be within this interval by increasing or decreasing propofol infusion by 1 mg/kg after additional bolus dose of propofol (1 mg/kg). 3. Insertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations. All devices are deflated a lubricated prior to use. Once inserted, the cuff is be inflated with a manometer up to 60 cm H20 Data recorded: size of airway device, time an number of attempts. 4. Anesthesia maintenance will be ensured by 50% O2/air with 0.1-0.4 µ kg/min-1 remifentanil and 50-150 µ kg/ min-1 (4-10 mg/kg/hr) propofol IV infusion 5. Functionality of the gastric drainage channel of the airway device: passage of a 14 G size tube. 6. Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and at 2 minutes after airway device insertion (T1), 10 minutes after insufflation (T2), before desufflation (T3), before removal of airway device (T4). The maximum pressure allowed is 40 cm H2O. 7. Ventilatory mechanics and parameters and hemodynamic parameters are measured at baseline, and at T1, T2, T3 and T4. 8. Perioperative complications: Cough, vomiting, laryngeal spasm, laryngeal Stridor, airway intervention requirements, hypoxia (SpO2 \< 92%) 9. Removal of the airway device: Presence of blood - 3 level grading (1:no blood; 2: trace amounts of blood; 3: clear amounts of blood). Complications: sore throat ( VAS:10-point scale), dysphonia (yes/no), dysphagia (yes/no).
Interventions
Evaluation of clinical performance in terms of Insertion, ventilation and complications
DEVICEi-gel Evaluation
Evaluation of clinical performance in terms of Insertion,ventilation and complications
Sponsors
Dokuz Eylul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. American Society of Anesthesiologists classification group I-II 2. between 18-65 years 3. undergoing elective laparoscopic gynecological surgery
Exclusion criteria
1. Those with any neck or upper respiratory tract pathology 2. Those at risk of gastric content regurgitation/aspiration (previous upper Gastrointestinal system surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcers, full stomach, pregnancy) 3. Those with low pulmonary compliance or high airway resistance (chronic pulmonary diseases) 4. Obese patients (BMI \>35) 5. Those with throat pain, dysphagia and dysphonia 6. Those with possible or previous difficult airway 7. Those with operations planned for longer than 4 hours 8. Conversion to laparatomy 9. Neuromuscular blocking agent used
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Airway Seal Pressure Values | At baseline and at 15, 30 and 60 minutes | This value is important as it indicates the feasibility of positive pressure ventilation and the degree of airway protection from supracuff soiling. It is also used in LMA studies as an index of successful placement.Airway pressures of ≈20 cm H2O are typically required in routine practice. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastric Tube Insertion | following airway device insertion up to 5 minutes | Number of Participants According to Ease of Gastric Tube Insertion.Ease of passage of a gastric tube as: very easy, easy, difficult or very difficult. |
| Postoperative Pharyngolaryngeal Morbidity | postoperative first hour and 24th hour | Sore throat evaluted by Visual Analogue Scale. The visual analog scale, also known as the graphic rating scale is a simple, valid and reliable subjective measure. Scores are ranked on a 10-cm line that stretches between two extremes - no pain and worst pain. Total range provided0 (no pain) to 10 (worst pain). |
| Sufficiency of Pneumoperitoneum | baseline | Number of Participants with Sufficiency of Pneumoperitoneum. Sufficiency of pneumoperitoneum for the surgical procedure according to surgeon, described as sufficient or insufficient questionaire. |
| Visual Quality | during pneumoperitoneum | quality of surgical view will evaluate by the scala. quality of surgical view will be assessed with points from 1 to 4 by the surgeon blind to the airway device; (1:best, 4: worst). |
| Dysphonia With Yes/no. | postoperative first hour and 24th hour | We evaluated while a patient was talking with us that the patient has dysphonia or not . |
| Disphagia | postoperative first hour and 24th hour | We asked the question that you have a pain while you were swallowing, yes or not. |
| Mean Airway Pressure Values | At baseline and at 15, 30 and 60 minutes | Mean airway pressure typically refers to the mean pressure applied during positive-pressure mechanical ventilation. Mean airway pressure correlates with alveolar ventilation, arterial oxygenation, hemodynamic performance, and barotrauma. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Laryngeal Mask Supreme Insertion of the Laryngeal mask Supreme and evaluation of its clinical performance
Laryngeal mask Supreme Evaluation: Evaluation of clinical performance in terms of Insertion, ventilation and complications | 51 |
| I-gel Insertion of the i-gel and evaluation of its clinical performance
i-gel Evaluation: Evaluation of clinical performance in terms of Insertion,ventilation and complications | 55 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | can not replace LMA | 1 | 0 |
| Overall Study | convert to laparatomy | 2 | 2 |
| Overall Study | destaturation | 1 | 0 |
Baseline characteristics
| Characteristic | I-gel | Total | Laryngeal Mask Supreme |
|---|---|---|---|
| Age, Continuous | 36.44 years STANDARD_DEVIATION 8.31 | 35.49 years STANDARD_DEVIATION 8.82 | 34.55 years STANDARD_DEVIATION 9.34 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Turkey | 55 Participants | 106 Participants | 51 Participants |
| Sex: Female, Male Female | 55 Participants | 106 Participants | 51 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 55 |
| other Total, other adverse events | 0 / 51 | 0 / 55 |
| serious Total, serious adverse events | 0 / 51 | 0 / 55 |
Outcome results
Primary
Airway Seal Pressure Values
This value is important as it indicates the feasibility of positive pressure ventilation and the degree of airway protection from supracuff soiling. It is also used in LMA studies as an index of successful placement.Airway pressures of ≈20 cm H2O are typically required in routine practice.
Time frame: At baseline and at 15, 30 and 60 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Laryngeal Mask Supreme | Airway Seal Pressure Values | baseline | 31.20 cm H2O | Standard Deviation 8.07 |
| Laryngeal Mask Supreme | Airway Seal Pressure Values | at 15 min | 30.10 cm H2O | Standard Deviation 6.48 |
| Laryngeal Mask Supreme | Airway Seal Pressure Values | at 30 min | 29.92 cm H2O | Standard Deviation 6.19 |
| Laryngeal Mask Supreme | Airway Seal Pressure Values | at 60 min | 30.31 cm H2O | Standard Deviation 6.19 |
| I-gel | Airway Seal Pressure Values | at 60 min | 29.13 cm H2O | Standard Deviation 6.47 |
| I-gel | Airway Seal Pressure Values | baseline | 27.58 cm H2O | Standard Deviation 7.16 |
| I-gel | Airway Seal Pressure Values | at 30 min | 28.71 cm H2O | Standard Deviation 6.65 |
| I-gel | Airway Seal Pressure Values | at 15 min | 28.76 cm H2O | Standard Deviation 7.33 |
Secondary
Disphagia
We asked the question that you have a pain while you were swallowing, yes or not.
Time frame: postoperative first hour and 24th hour
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Laryngeal Mask Supreme | Disphagia | at first hour-no | 47 Participants |
| Laryngeal Mask Supreme | Disphagia | at 24th hour-no | 51 Participants |
| I-gel | Disphagia | at first hour-no | 54 Participants |
| I-gel | Disphagia | at 24th hour-no | 55 Participants |
Secondary
Dysphonia With Yes/no.
We evaluated while a patient was talking with us that the patient has dysphonia or not .
Time frame: postoperative first hour and 24th hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Laryngeal Mask Supreme | Dysphonia With Yes/no. | at first hour-no | 51 Number of Participants without Dysphonia |
| Laryngeal Mask Supreme | Dysphonia With Yes/no. | at 24th hour-no | 51 Number of Participants without Dysphonia |
| I-gel | Dysphonia With Yes/no. | at first hour-no | 55 Number of Participants without Dysphonia |
| I-gel | Dysphonia With Yes/no. | at 24th hour-no | 55 Number of Participants without Dysphonia |
Secondary
Gastric Tube Insertion
Number of Participants According to Ease of Gastric Tube Insertion.Ease of passage of a gastric tube as: very easy, easy, difficult or very difficult.
Time frame: following airway device insertion up to 5 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Laryngeal Mask Supreme | Gastric Tube Insertion | very easy | 33 participants |
| Laryngeal Mask Supreme | Gastric Tube Insertion | easy | 18 participants |
| Laryngeal Mask Supreme | Gastric Tube Insertion | difficult | 0 participants |
| Laryngeal Mask Supreme | Gastric Tube Insertion | very difficult | 0 participants |
| I-gel | Gastric Tube Insertion | very difficult | 6 participants |
| I-gel | Gastric Tube Insertion | very easy | 12 participants |
| I-gel | Gastric Tube Insertion | difficult | 10 participants |
| I-gel | Gastric Tube Insertion | easy | 27 participants |
Secondary
Mean Airway Pressure Values
Mean airway pressure typically refers to the mean pressure applied during positive-pressure mechanical ventilation. Mean airway pressure correlates with alveolar ventilation, arterial oxygenation, hemodynamic performance, and barotrauma.
Time frame: At baseline and at 15, 30 and 60 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Laryngeal Mask Supreme | Mean Airway Pressure Values | baseline | 5.84 cm H2O | Standard Deviation 0.92 |
| Laryngeal Mask Supreme | Mean Airway Pressure Values | at 60 min | 6.51 cm H2O | Standard Deviation 1.15 |
| Laryngeal Mask Supreme | Mean Airway Pressure Values | at 15 min | 7.84 cm H2O | Standard Deviation 1.23 |
| Laryngeal Mask Supreme | Mean Airway Pressure Values | at 30 min | 7.45 cm H2O | Standard Deviation 1.31 |
| I-gel | Mean Airway Pressure Values | at 15 min | 7.87 cm H2O | Standard Deviation 1.47 |
| I-gel | Mean Airway Pressure Values | at 60 min | 6.29 cm H2O | Standard Deviation 1.21 |
| I-gel | Mean Airway Pressure Values | baseline | 5.82 cm H2O | Standard Deviation 1.09 |
| I-gel | Mean Airway Pressure Values | at 30 min | 7.27 cm H2O | Standard Deviation 1.39 |
Secondary
Postoperative Pharyngolaryngeal Morbidity
Sore throat evaluted by Visual Analogue Scale. The visual analog scale, also known as the graphic rating scale is a simple, valid and reliable subjective measure. Scores are ranked on a 10-cm line that stretches between two extremes - no pain and worst pain. Total range provided0 (no pain) to 10 (worst pain).
Time frame: postoperative first hour and 24th hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Laryngeal Mask Supreme | Postoperative Pharyngolaryngeal Morbidity | at first hour | 0.43 units on a scale | Standard Deviation 1.02 |
| Laryngeal Mask Supreme | Postoperative Pharyngolaryngeal Morbidity | 24th hour | 0.02 units on a scale | Standard Deviation 0.14 |
| I-gel | Postoperative Pharyngolaryngeal Morbidity | at first hour | 0.16 units on a scale | Standard Deviation 0.06 |
| I-gel | Postoperative Pharyngolaryngeal Morbidity | 24th hour | 0.00 units on a scale | Standard Deviation 0 |
Secondary
Sufficiency of Pneumoperitoneum
Number of Participants with Sufficiency of Pneumoperitoneum. Sufficiency of pneumoperitoneum for the surgical procedure according to surgeon, described as sufficient or insufficient questionaire.
Time frame: baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Laryngeal Mask Supreme | Sufficiency of Pneumoperitoneum | sufficient | 50 Participants |
| Laryngeal Mask Supreme | Sufficiency of Pneumoperitoneum | insufficient | 1 Participants |
| I-gel | Sufficiency of Pneumoperitoneum | sufficient | 55 Participants |
| I-gel | Sufficiency of Pneumoperitoneum | insufficient | 0 Participants |
Secondary
Visual Quality
quality of surgical view will evaluate by the scala. quality of surgical view will be assessed with points from 1 to 4 by the surgeon blind to the airway device; (1:best, 4: worst).
Time frame: during pneumoperitoneum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laryngeal Mask Supreme | Visual Quality | 3.941 units on a scale | Standard Deviation 0.42 |
| I-gel | Visual Quality | 3.945 units on a scale | Standard Deviation 0.4 |