Inguinal Hernia, Inguinal Hernia Bilateral, Inguinal Hernia, Indirect, Inguinal Hernia Unilateral
Conditions
Brief summary
This prospective randomized study will evaluate the effectiveness of laryngeal mask airway (LMA) versus endotracheal intubation (ETT) for patients undergoing laparoscopic inguinal hernia at CMH.
Detailed description
This study aims to evaluate the effectiveness during general anesthesia of laryngeal mask airway versus endotracheal tube for laparoscopic inguinal hernia repair. There are limited pediatric literature evaluating the use of laryngeal mask airway for laparoscopic procedures compared with traditional endotracheal intubation. This study aims to add to this literature in providing information comparing the two techniques. The rationale for this study is to show that general anesthesia with laryngeal mask airway is an effective and non-inferior technique compared with general anesthesia with endotracheal intubation in pediatric patients undergoing laparoscopic inguinal hernia repair and may offer benefits in terms of efficiency of care and respiratory complications.
Interventions
DEVICELaryngeal Mask Airway
Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.
DEVICEEndotracheal Tube Device
Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.
Sponsors
Children's Mercy Hospital Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 8 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing laparoscopic inguinal hernia repair. * Ages 12 months to 8 years of age * American Society of Anesthesiologists Physical Status Classification ASA 1 or 2 * ASA 1- A normal, healthy patient * ASA 2- A patient with mild systemic disease * Elective with appropriate NPO status * English speakers * Spanish speakers
Exclusion criteria
* Patients with current gastroesophageal reflux * Obesity (CDC \>= 95th %ile) * Contraindications to study protocol medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation | Patients will have oxygen saturation measured directly after placement airway device, the first oxygen saturation recorded five minutes after the start of surgery, and immediately prior to removal airway device, assessed up to 2 hours. | Oyxgen saturation will be measured by pulse oximetry in percent saturation at three time points during the anesthetic |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| End-tidal Carbon Dioxide Measured by Capnography in mm Hg | Patients will have end-tidal carbon dioxide measured directly after placement of device, the first end-tidal carbon dioxide measurement recorded five minutes after the start of surgery, and immediately prior to removal of device, assessed up to 2 hours. | Patients will have end-tidal carbon dioxide measured by capnography in mm Hg at three standardized time points during anesthesia. |
| Peak Airway Pressure Will be Measured in cm H2O | Patients will have peak airway pressure measured directly after placement airway device, the first airway pressure recorded five minutes after the start of surgery, and immediately prior to removal airway device, assessed up to 2 hours. | Patients will have peak airway pressure in cm H2O measured at three standardized time points during anesthesia. |
| Documentation of Laryngospasm Occurrence | Patients will have the occurrence of laryngospasm documented at any time point during the surgery, assessed up to 2 hours. | Will document if laryngospasm occurs in both groups at any time during the surgery. |
| Documentation of Oxygen Desaturation | Patients will have the occurrence of oxygen desaturation documented if it occurs at any time point during the surgery, assessed up to 2 hours. | Will document if oxygen desaturation occurs at any time during the surgery as defined as an oxygen saturation of less than 90%. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort A: Receives Laryngeal Mask Airway Device In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.
Laryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion. | 25 |
| Cohort B: Receives Endotracheal Tube Device In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.
Endotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not receive allocated intervention (Patient received ETT per surgeon) | 1 | 0 |
| Overall Study | Did not received allocated intervention (no airway device documented in EMR) | 1 | 1 |
| Overall Study | Surgery not performed (hernia not identified on diagnostic laparoscopy) | 0 | 3 |
| Overall Study | Surgery was not performed laparoscopically | 4 | 2 |
Baseline characteristics
| Characteristic | Cohort B: Receives Endotracheal Tube Device | Total | Cohort A: Receives Laryngeal Mask Airway Device |
|---|---|---|---|
| Age, Categorical <=18 years | 25 Participants | 50 Participants | 25 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 3.1 years | 3.21 years | 3.5 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 25 participants | 50 participants | 25 participants |
| Sex: Female, Male Female | 6 Participants | 13 Participants | 7 Participants |
| Sex: Female, Male Male | 19 Participants | 37 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation
Oyxgen saturation will be measured by pulse oximetry in percent saturation at three time points during the anesthetic
Time frame: Patients will have oxygen saturation measured directly after placement airway device, the first oxygen saturation recorded five minutes after the start of surgery, and immediately prior to removal airway device, assessed up to 2 hours.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A: Receives Laryngeal Mask Airway Device | Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation | SpO2 after placement airway device | 100 Percent Saturation |
| Cohort A: Receives Laryngeal Mask Airway Device | Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation | SpO2 5 minutes after surgery start | 100 Percent Saturation |
| Cohort A: Receives Laryngeal Mask Airway Device | Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation | SpO2 prior to airway device removal | 100 Percent Saturation |
| Cohort B: Receives Endotracheal Tube Device | Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation | SpO2 after placement airway device | 100 Percent Saturation |
| Cohort B: Receives Endotracheal Tube Device | Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation | SpO2 5 minutes after surgery start | 100 Percent Saturation |
| Cohort B: Receives Endotracheal Tube Device | Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation | SpO2 prior to airway device removal | 100 Percent Saturation |
Secondary
Documentation of Laryngospasm Occurrence
Will document if laryngospasm occurs in both groups at any time during the surgery.
Time frame: Patients will have the occurrence of laryngospasm documented at any time point during the surgery, assessed up to 2 hours.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A: Receives Laryngeal Mask Airway Device | Documentation of Laryngospasm Occurrence | 0 Presence of laryngospasm |
| Cohort B: Receives Endotracheal Tube Device | Documentation of Laryngospasm Occurrence | 0 Presence of laryngospasm |
Secondary
Documentation of Oxygen Desaturation
Will document if oxygen desaturation occurs at any time during the surgery as defined as an oxygen saturation of less than 90%.
Time frame: Patients will have the occurrence of oxygen desaturation documented if it occurs at any time point during the surgery, assessed up to 2 hours.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A: Receives Laryngeal Mask Airway Device | Documentation of Oxygen Desaturation | 1 Occurence of oxygen desaturation |
| Cohort B: Receives Endotracheal Tube Device | Documentation of Oxygen Desaturation | 1 Occurence of oxygen desaturation |
Secondary
End-tidal Carbon Dioxide Measured by Capnography in mm Hg
Patients will have end-tidal carbon dioxide measured by capnography in mm Hg at three standardized time points during anesthesia.
Time frame: Patients will have end-tidal carbon dioxide measured directly after placement of device, the first end-tidal carbon dioxide measurement recorded five minutes after the start of surgery, and immediately prior to removal of device, assessed up to 2 hours.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A: Receives Laryngeal Mask Airway Device | End-tidal Carbon Dioxide Measured by Capnography in mm Hg | ETCO2 after placement of airway device | 44 millimeters mercury (mm Hg) |
| Cohort A: Receives Laryngeal Mask Airway Device | End-tidal Carbon Dioxide Measured by Capnography in mm Hg | ETCO2 5 minutes after surgery start | 47 millimeters mercury (mm Hg) |
| Cohort A: Receives Laryngeal Mask Airway Device | End-tidal Carbon Dioxide Measured by Capnography in mm Hg | ETCO2 prior to removal of airway device | 45 millimeters mercury (mm Hg) |
| Cohort B: Receives Endotracheal Tube Device | End-tidal Carbon Dioxide Measured by Capnography in mm Hg | ETCO2 after placement of airway device | 43 millimeters mercury (mm Hg) |
| Cohort B: Receives Endotracheal Tube Device | End-tidal Carbon Dioxide Measured by Capnography in mm Hg | ETCO2 5 minutes after surgery start | 48 millimeters mercury (mm Hg) |
| Cohort B: Receives Endotracheal Tube Device | End-tidal Carbon Dioxide Measured by Capnography in mm Hg | ETCO2 prior to removal of airway device | 49 millimeters mercury (mm Hg) |
Secondary
Peak Airway Pressure Will be Measured in cm H2O
Patients will have peak airway pressure in cm H2O measured at three standardized time points during anesthesia.
Time frame: Patients will have peak airway pressure measured directly after placement airway device, the first airway pressure recorded five minutes after the start of surgery, and immediately prior to removal airway device, assessed up to 2 hours.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A: Receives Laryngeal Mask Airway Device | Peak Airway Pressure Will be Measured in cm H2O | Peak airway pressure prior to removal of airway device | 7 cm H20 |
| Cohort A: Receives Laryngeal Mask Airway Device | Peak Airway Pressure Will be Measured in cm H2O | Peak airway pressure after placement of airway device | 11 cm H20 |
| Cohort A: Receives Laryngeal Mask Airway Device | Peak Airway Pressure Will be Measured in cm H2O | Peak airway pressure 5 minutes after surgery start | 13 cm H20 |
| Cohort B: Receives Endotracheal Tube Device | Peak Airway Pressure Will be Measured in cm H2O | Peak airway pressure 5 minutes after surgery start | 16 cm H20 |
| Cohort B: Receives Endotracheal Tube Device | Peak Airway Pressure Will be Measured in cm H2O | Peak airway pressure after placement of airway device | 14 cm H20 |
| Cohort B: Receives Endotracheal Tube Device | Peak Airway Pressure Will be Measured in cm H2O | Peak airway pressure prior to removal of airway device | 11 cm H20 |