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The purpose of this research study is to compare difference between breathing by oneself or with the partial help from an anesthesia machine in infants under general anesthesia.
Hypothesis: Infants undergoing general anesthesia with a PLMA™ will be better ventilated (improved breathing) with the help of the breathing machine versus breathing on their own.
The laryngeal mask airway (LMA) is a breathing device that sits above the vocal cords and allows the patient to breathe in and out adequately under general anesthesia (GA). The ProSeal™ laryngeal mask airway (PLMA™) is a specialized type of LMA with a design that permits the delivery of higher pressures to help the patient breathe in and out (ventilate) and also contains a channel to suction the stomach.
Infants under GA may breathe through a PLMA in different ways. Spontaneous ventilation consists of the infants breathing on their own through a PLMA™. Pressure support ventilation allows the patient to breathe on their own with additional help from the anesthesia machine. Pressure control ventilation allows the patient to breathe with the help of an anesthesia machine.
An infant undergoing surgery requires a deep level of general anesthesia which negatively affects their ability to ventilate. Thus, infants may not breathe in oxygen and carbon dioxide out adequately at this level of anesthesia and it may be beneficial to provide some level of support to enhance carbon dioxide exchange and to avoid hypoventilation.
This study will attempt to determine whether pressure support ventilation improves ventilation in infants undergoing outpatient surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spontaneous ventilation | Experimental |
| |
| Pressure support ventilation | Experimental |
| |
| Pressure control ventilation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spontaneous ventilation | Other | The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. | Mean values of end-tidal carbon dioxide (ETCO2) and tidal volume (TV) between 5 and 45 minutes compared between the spontaneous ventilation (SV) and pressure support ventilation groups (PSV). | Up to 45 minutes |
| Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups | Mean values of ETCO2 and TV between 5 and 45 minutes compared between the SV and Pressure control ventilation (PCV) groups. | Up to 45 minutes |
| Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups | Mean values of ETCO2 and TV between 5 and 45 minutes compared between the PSV and PCV groups | up to 45 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Values of Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups. | Mean values of respiratory rate between 5 and 45 minutes compared between spontaneous ventilation and pressure support ventilation groups. | Up to 45 minutes |
| Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Templeton, M.D. | Wake Forest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 4003736 | Background | Brain AI, McGhee TD, McAteer EJ, Thomas A, Abu-Saad MA, Bushman JA. The laryngeal mask airway. Development and preliminary trials of a new type of airway. Anaesthesia. 1985 Apr;40(4):356-61. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Spontaneous Ventilation | Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery. |
| FG001 | Pressure Support Ventilation | Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery. |
| FG002 | Pressure Control Ventilation | Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Spontaneous Ventilation | Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery. |
| BG001 | Pressure Support Ventilation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. | Mean values of end-tidal carbon dioxide (ETCO2) and tidal volume (TV) between 5 and 45 minutes compared between the spontaneous ventilation (SV) and pressure support ventilation groups (PSV). | Posted | Mean | Standard Deviation | cc/kg | Up to 45 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spontaneous Ventilation | Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| T. Wesley Templeton, MD | Anesthesiology | 336-716-4498 | ttemplet@wakehealth.edu |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Pressure support ventilation | Device | The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery. |
|
| Pressure control ventilation | Device | The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery. |
|
Mean values of respiratory rate between 5 and 45 minutes compared between the spontaneous ventilation and pressure control ventilation groups. |
| Up to 45 minutes |
| Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups. | Mean values of respiratory rate between 5 and 45 minutes compared between pressure support ventilation and pressure control ventilation groups. | Up to 45 minutes |
Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
| BG002 | Pressure Control Ventilation | Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery. |
| BG003 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| PLMA Size (ProSeal laryngeal mask airway) | Count of Participants | Participants |
|
| Induction Time | Mean | Standard Deviation | minutes |
|
|
|
| Primary | Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups | Mean values of ETCO2 and TV between 5 and 45 minutes compared between the SV and Pressure control ventilation (PCV) groups. | Posted | Mean | Standard Deviation | cc/kg | Up to 45 minutes |
|
|
|
| Primary | Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups | Mean values of ETCO2 and TV between 5 and 45 minutes compared between the PSV and PCV groups | Posted | Mean | Standard Deviation | cc/kg | up to 45 minutes |
|
|
|
| Secondary | Mean Values of Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups. | Mean values of respiratory rate between 5 and 45 minutes compared between spontaneous ventilation and pressure support ventilation groups. | Posted | Mean | Standard Deviation | breaths per minute | Up to 45 minutes |
|
|
|
| Secondary | Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups. | Mean values of respiratory rate between 5 and 45 minutes compared between the spontaneous ventilation and pressure control ventilation groups. | Posted | Mean | Standard Deviation | breaths per minute | Up to 45 minutes |
|
|
|
| Secondary | Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups. | Mean values of respiratory rate between 5 and 45 minutes compared between pressure support ventilation and pressure control ventilation groups. | Posted | Mean | Standard Deviation | breaths per minute | Up to 45 minutes |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Pressure Support Ventilation | Pressure support ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Pressure Control Ventilation | Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery. | 0 | 11 | 0 | 11 | 0 | 11 |
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