A Comparison of Different Ventilation Strategies in Children Using the Proseal™ Laryngeal Mask Airway

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT00966433
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 3
• Duration (Months): 2
• Patients Per Site Per Month: 16.5

Study Details

Study Description

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 children under general anesthesia.

Condition or Disease	Intervention/Treatment	Phase
Intraoperative Ventilation	Procedure: Spontaneous ventilation; Device: Pressure support Ventilation; Device: Pressure control ventilation	N/A

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™ LMA (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.

Children under GA may breathe through a PLMA in different ways. Spontaneous ventilation consists of the children 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.

A child undergoing surgery requires a deep level of general anesthesia which negatively affects their ability to ventilate. Thus, children 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 children undergoing outpatient surgery.

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Comparison of Different Ventilation Strategies in Children Using the Proseal™ Laryngeal Mask Airway
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Spontaneous ventilation Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.	Procedure: Spontaneous ventilation; The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.
Experimental: Pressure support ventilation Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.	Device: 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.
Active Comparator: Pressure control ventilation Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA.	Device: 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.

Outcome Measures

Primary Outcome Measures

1. Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. [up to 90 minutes]

   Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups will be calculated by subtracting the mean of End-tidal Carbon Dioxide from the PSV group to the SV group

2. Differences Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. [up to 90 minutes]

   Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. Measured in mL/Kg and will be calculated by subtracting the mean of tidal volume from the PSV group to the SV group

3. Mean Values of ETCO2 in SV and PCV Groups [up to 90 minutes]

   Mean Values of ETCO2 in SV and PCV groups reported in mmHg

4. Mean Tidal Volume Values Compared Between SV and PCV Groups [up to 90 minutes]

   Mean Tidal Volume Values compared between SV and PCV Groups. Measured in mL/kg

5. Mean Values of ETCO2 Between the PSV and PCV Groups [up to 90 minutes]

   Mean Values of ETCO2 between the PSV and PCV Groups. Measured in mmHg

6. Mean Values of Tidal Volume Between the PSV and PCV Groups [up to 90 minutes]

   Mean Values of Tidal Volume Between the PSV and PCV Groups. Measured in mL/kg

Secondary Outcome Measures

1. Differences in Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups. [up to 90 minutes]

   Differences in respiratory rates between spontaneous ventilation and pressure support ventilation groups will be calculated by subtracting the mean of from the respiratory rates PSV group to the SV group.

2. Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups. [up to 90 minutes]

3. Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups. [up to 90 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Months to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ASA physical classification 1,2 (Healthy or relatively healthy children)

• Subjects scheduled for outpatient surgical procedures.

• Surgical procedure anticipated to be < 90 minutes

• Subject weight of ≤ 20 kg (44 lbs)

• Subject age of 12 months to 5 years (inclusive)

Exclusion Criteria:

• Inpatient

• ASA physical classification of 3, 4 or E (sick children)

• Risk of aspiration

• Subjects with malignant hyperthermia or family history of malignant hyperthermia

• Subjects with tracheostomies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

• Principal Investigator: Thomas W Templeton, M.D., Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bagshaw O. The size 1.5 laryngeal mask airway (LMA) in paediatric anaesthetic practice. Paediatr Anaesth. 2002 Jun;12(5):420-3.
• 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.
• Garcia-Fernandez J, Tusman G, Suarez-Sipmann F, Llorens J, Soro M, Belda JF. Programming pressure support ventilation in pediatric patients in ambulatory surgery with a laryngeal mask airway. Anesth Analg. 2007 Dec;105(6):1585-91, table of contents.
• Goldmann K, Jakob C. A randomized crossover comparison of the size 2 1/2 laryngeal mask airway ProSeal versus laryngeal mask airway-Classic in pediatric patients. Anesth Analg. 2005 Jun;100(6):1605-1610. doi: 10.1213/01.ANE.0000152640.25078.90.
• Keidan I, Berkenstadt H, Segal E, Perel A. Pressure versus volume-controlled ventilation with a laryngeal mask airway in paediatric patients. Paediatr Anaesth. 2001 Nov;11(6):691-4.
• Lardner DR, Cox RG, Ewen A, Dickinson D. [Comparison of laryngeal mask airway (LMA)- Proseal and the LMA-Classic in ventilated children receiving neuromuscular blockade]. Can J Anaesth. 2008 Jan;55(1):29-35. doi: 10.1007/BF03017594. Erratum in: Can J Anaesth. 2008 May;55(5):321.
• Licina A, Chambers NA, Hullett B, Erb TO, von Ungern-Sternberg BS. Lower cuff pressures improve the seal of pediatric laryngeal mask airways. Paediatr Anaesth. 2008 Oct;18(10):952-6. doi: 10.1111/j.1460-9592.2008.02706.x. Epub 2008 Jul 21.
• Lopéz Gil ML, Brimacombe J, Clar B. Sevoflurane versus propofol for induction and maintenance of anaesthesia with the laryngeal mask airway in children. Paediatr Anaesth. 1999;9(6):485-90.
• Lopez-Gil M, Brimacombe J, Alvarez M. Safety and efficacy of the laryngeal mask airway. A prospective survey of 1400 children. Anaesthesia. 1996 Oct;51(10):969-72.
• Mason DG, Bingham RM. The laryngeal mask airway in children. Anaesthesia. 1990 Sep;45(9):760-3.
• Shimbori H, Ono K, Miwa T, Morimura N, Noguchi M, Hiroki K. Comparison of the LMA-ProSeal and LMA-Classic in children. Br J Anaesth. 2004 Oct;93(4):528-31. Epub 2004 Aug 6.
• Wheeler M. ProSeal laryngeal mask airway in 120 pediatric surgical patients: a prospective evaluation of characteristics and performance. Paediatr Anaesth. 2006 Mar;16(3):297-301.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT00966433
• Other Study ID Numbers: IRB00009452
• First Posted: Aug 27, 2009
• Last Update Posted: Dec 5, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Wake Forest University Health Sciences: Proseal™ LMA; children; ventilation; general anesthesia; Children under general anesthesia for outpatient surgery

Study Results

Participant Flow

Arm/Group Title	Spontaneous Ventilation	Pressure Support Ventilation	Pressure Control Ventilation
Arm/Group Description	Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation. Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.	Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA. 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.	Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA. 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.
Period Title: Overall Study
STARTED	11	11	11
COMPLETED	10	10	11
NOT COMPLETED	1	1	0

Baseline Characteristics

Arm/Group Title	Spontaneous Ventilation	Pressure Support Ventilation	Pressure Control Ventilation	Total
Arm/Group Description	Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation. Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.	Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA. 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.	Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA. 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.	Total of all reporting groups
Overall Participants	10	10	11	31
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	28 (18)	32 (17)	27 (16)	28.9 (17.01)
Sex: Female, Male (Count of Participants)
Female	1 10%	1 10%	1 9.1%	3 9.7%
Male	9 90%	9 90%	10 90.9%	28 90.3%
ASA Status (Count of Participants)
I	9 90%	8 80%	9 81.8%	26 83.9%
II	1 10%	2 20%	2 18.2%	5 16.1%

Outcome Measures

1. Primary Outcome

Title	Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.
Description	Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups will be calculated by subtracting the mean of End-tidal Carbon Dioxide from the PSV group to the SV group
Time Frame	up to 90 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spontaneous Ventilation	Pressure Support Ventilation
Arm/Group Description	Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation. Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery	Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA. 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.
Measure Participants	10	10
Mean (Standard Deviation) [mmHg]	55.2 (5.5)	47 (6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Spontaneous Ventilation, Pressure Support Ventilation
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.0051
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-8.2
	Confidence Interval	(2-Sided) 95%; -13.61 to -2.79
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Differences Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.
Description	Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. Measured in mL/Kg and will be calculated by subtracting the mean of tidal volume from the PSV group to the SV group
Time Frame	up to 90 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spontaneous Ventilation	Pressure Support Ventilation
Arm/Group Description	Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation. Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.	Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA. 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.
Measure Participants	10	10
Mean (Standard Deviation) [mL/kg]	4.0 (.8)	7.6 (.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Spontaneous Ventilation, Pressure Support Ventilation
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.0001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.6
	Confidence Interval	(2-Sided) 95%; 2.97 to 4.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Mean Values of ETCO2 in SV and PCV Groups
Description	Mean Values of ETCO2 in SV and PCV groups reported in mmHg
Time Frame	up to 90 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spontaneous Ventilation	Pressure Control Ventilation
Arm/Group Description	Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation. Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.	Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA. 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.
Measure Participants	10	11
Mean (Standard Deviation) [mmHg]	55.2 (5.5)	43.1 (0.8)

4. Primary Outcome

Title	Mean Tidal Volume Values Compared Between SV and PCV Groups
Description	Mean Tidal Volume Values compared between SV and PCV Groups. Measured in mL/kg
Time Frame	up to 90 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spontaneous Ventilation	Pressure Control Ventilation
Arm/Group Description	Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation. Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.	Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA. 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.
Measure Participants	10	11
Mean (Standard Deviation) [mL/kg]	4.0 (0.8)	7.6 (0.2)

5. Primary Outcome

Title	Mean Values of ETCO2 Between the PSV and PCV Groups
Description	Mean Values of ETCO2 between the PSV and PCV Groups. Measured in mmHg
Time Frame	up to 90 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pressure Support Ventilation	Pressure Control Ventilation
Arm/Group Description	Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA. 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.	Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA. 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.
Measure Participants	10	11
Mean (Standard Deviation) [mmHg]	47.0 (6.0)	43.1 (0.8)

6. Primary Outcome

Title	Mean Values of Tidal Volume Between the PSV and PCV Groups
Description	Mean Values of Tidal Volume Between the PSV and PCV Groups. Measured in mL/kg
Time Frame	up to 90 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pressure Support Ventilation	Pressure Control Ventilation
Arm/Group Description	Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA. 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.	Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA. 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.
Measure Participants	10	11
Mean (Standard Deviation) [mL/kg]	7.6 (0.5)	7.6 (0.2)

7. Secondary Outcome

Title	Differences in Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.
Description	Differences in respiratory rates between spontaneous ventilation and pressure support ventilation groups will be calculated by subtracting the mean of from the respiratory rates PSV group to the SV group.
Time Frame	up to 90 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spontaneous Ventilation	Pressure Support Ventilation
Arm/Group Description	Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation. Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.	Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA. 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.
Measure Participants	10	10
Mean (Standard Deviation) [breath/min]	28.1 (5.3)	14.2 (5.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Spontaneous Ventilation, Pressure Support Ventilation
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.0001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-13.9
	Confidence Interval	(2-Sided) 95%; -18.88 to -8.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.
Time Frame	up to 90 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spontaneous Ventilation	Pressure Control Ventilation
Arm/Group Description	Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation. Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.	Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA. 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.
Measure Participants	10	11
Mean (Standard Deviation) [breath/min]	28.1 (5.3)	21.2 (3.0)

9. Secondary Outcome

Title	Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.
Time Frame	up to 90 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pressure Support Ventilation	Pressure Control Ventilation
Arm/Group Description	Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA. 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.	Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA. 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.
Measure Participants	10	11
Mean (Standard Deviation) [breath/min]	14.2 (5.3)	21.2 (3.0)

Adverse Events

Time Frame	up to 90 minutes
Arm/Group Title	Spontaneous Ventilation		Pressure Support Ventilation		Pressure Control Ventilation
Arm/Group Description	Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation. Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.		Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA. 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.		Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA. 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.
All Cause Mortality
	Spontaneous Ventilation		Pressure Support Ventilation		Pressure Control Ventilation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/11 (0%)
Serious Adverse Events
	Spontaneous Ventilation		Pressure Support Ventilation		Pressure Control Ventilation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Spontaneous Ventilation		Pressure Support Ventilation		Pressure Control Ventilation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.