Ventilation
Conditions
Keywords
Proseal™ LMA, infants, ventilation, general anesthesia, outpatient surgery
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPressure 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.
The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
Sponsors
Wake Forest University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 11 Months
Healthy volunteers
No
Inclusion criteria
1. ASA (American Society of Anesthesiologists) physical classification of 1 or 2 2. Outpatient surgical procedures 3. Surgical procedure anticipated to be \< 90 minutes 4. Subject age of 1 - 11 months (inclusive)
Exclusion criteria
1. Inpatient- Such individuals may have underlying disease processes which puts them at an increased risk under general anesthesia for hypoventilation 2. ASA physical classification of 3, 4 or E 3. Premature infants or infants \< 44 weeks post-conceptual age 4. Risk of aspiration- Intubation with an endotracheal tube may be required for general anesthesia. 5. Patients with malignant hyperthermia or family history of malignant hyperthermia- Administration of inhalational agents for general anesthesia is contraindicated. 6. Patients with tracheostomies- The individual's airway is already established and PLMA™ placement is not required.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. | Up to 45 minutes | 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). |
| Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups | Up to 45 minutes | Mean values of ETCO2 and TV between 5 and 45 minutes compared between the SV and Pressure control ventilation (PCV) groups. |
| Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups | up to 45 minutes | Mean values of ETCO2 and TV between 5 and 45 minutes compared between the PSV and PCV groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Values of Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups. | Up to 45 minutes | Mean values of respiratory rate between 5 and 45 minutes compared between spontaneous ventilation and pressure support ventilation groups. |
| Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups. | Up to 45 minutes | Mean values of respiratory rate between 5 and 45 minutes compared between the spontaneous ventilation and pressure control ventilation groups. |
| Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups. | Up to 45 minutes | Mean values of respiratory rate between 5 and 45 minutes compared between pressure support ventilation and pressure control ventilation groups. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spontaneous Ventilation Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery. | 10 |
| 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. | 12 |
| 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. | 11 |
| Total | 33 |
Baseline characteristics
| Characteristic | Spontaneous Ventilation | Pressure Support Ventilation | Pressure Control Ventilation | Total |
|---|---|---|---|---|
| Age, Customized Age | 7.1 months STANDARD_DEVIATION 2 | 7.3 months STANDARD_DEVIATION 2 | 6.9 months STANDARD_DEVIATION 1.9 | 7.1 months STANDARD_DEVIATION 2 |
| Induction Time | 9.5 minutes STANDARD_DEVIATION 5.9 | 8.6 minutes STANDARD_DEVIATION 3.3 | 9.6 minutes STANDARD_DEVIATION 3.1 | 9.2 minutes STANDARD_DEVIATION 4.3 |
| PLMA Size (ProSeal laryngeal mask airway) Size 1.5 | 8 Participants | 10 Participants | 8 Participants | 26 Participants |
| PLMA Size (ProSeal laryngeal mask airway) Size 2 | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 10 Participants | 11 Participants | 9 Participants | 30 Participants |
| Weight | 8 kg STANDARD_DEVIATION 1.7 | 8.5 kg STANDARD_DEVIATION 0.9 | 8.2 kg STANDARD_DEVIATION 1.3 | 8.2 kg STANDARD_DEVIATION 1.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 12 | 0 / 11 |
| other Total, other adverse events | 0 / 10 | 0 / 12 | 0 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 12 | 0 / 11 |
Outcome results
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).
Time frame: Up to 45 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spontaneous Ventilation | Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. | Mean Values of Tidal Volume | 4.5 cc/kg | Standard Deviation 0.3 |
| Spontaneous Ventilation | 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 | 51.8 cc/kg | Standard Deviation 2.9 |
| Pressure Support Ventilation | Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. | Mean Values of Tidal Volume | 7 cc/kg | Standard Deviation 0.5 |
| Pressure Support Ventilation | 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 | 49 cc/kg | Standard Deviation 1.5 |
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
Time frame: up to 45 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spontaneous Ventilation | Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups | ETCO2 | 49.0 cc/kg | Standard Deviation 1.5 |
| Spontaneous Ventilation | Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups | TV | 7.0 cc/kg | Standard Deviation 0.5 |
| Pressure Support Ventilation | Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups | ETCO2 | 48.3 cc/kg | Standard Deviation 1.6 |
| Pressure Support Ventilation | Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups | TV | 7.0 cc/kg | Standard Deviation 0.4 |
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.
Time frame: Up to 45 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spontaneous Ventilation | Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups | ETCO2 | 51.8 cc/kg | Standard Deviation 2.9 |
| Spontaneous Ventilation | Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups | TV | 4.5 cc/kg | Standard Deviation 0.3 |
| Pressure Support Ventilation | Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups | ETCO2 | 48.3 cc/kg | Standard Deviation 1.6 |
| Pressure Support Ventilation | Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups | TV | 7.0 cc/kg | Standard Deviation 0.4 |
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.
Time frame: Up to 45 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spontaneous Ventilation | Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups. | 25.1 breaths per minute | Standard Deviation 0.8 |
| Pressure Support Ventilation | Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups. | 22.3 breaths per minute | Standard Deviation 1.2 |
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.
Time frame: Up to 45 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spontaneous Ventilation | Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups. | 32.2 breaths per minute | Standard Deviation 2.2 |
| Pressure Support Ventilation | Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups. | 22.3 breaths per minute | Standard Deviation 1.2 |
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.
Time frame: Up to 45 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spontaneous Ventilation | Mean Values of Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups. | 32.2 breaths per minute | Standard Deviation 2.2 |
| Pressure Support Ventilation | Mean Values of Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups. | 25.1 breaths per minute | Standard Deviation 0.8 |