VentilationNCT03235817

A Comparison of Different Ventilation Strategies in Infants Using the PLMA™

A study testing Spontaneous ventilation and Pressure support ventilation in people with Ventilation, run by Wake Forest University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 1 month to 11 months
Conditions the study is for: Ventilation
What is being tested?: Spontaneous ventilation and Pressure support ventilation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: Dec 2009to Jul 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 month to 11 months
All sexes
No healthy volunteers
Child

Who may be able to join

ASA (American Society of Anesthesiologists) physical classification of 1 or 2
Outpatient surgical procedures
Surgical procedure anticipated to be < 90 minutes
Subject age of 1 - 11 months (inclusive)

Who cannot join

Inpatient- Such individuals may have underlying disease processes which puts them at an increased risk under general anesthesia for hypoventilation
ASA physical classification of 3, 4 or E
Premature infants or infants < 44 weeks post-conceptual age
Risk of aspiration- Intubation with an endotracheal tube may be required for general anesthesia.
Patients with malignant hyperthermia or family history of malignant hyperthermia- Administration of inhalational agents for general anesthesia is contraindicated.
Patients with tracheostomies- The individual's airway is already established and PLMA™ placement is not required.

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Comparison of Different Ventilation Strategies in Infants Using the Proseal™ Laryngeal Mask Airway

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.

Read the 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.

Conditions: Ventilation
Being tested: Spontaneous ventilation, Pressure support ventilation, Pressure control ventilation
Keywords: Proseal™ LMA, infants, ventilation, general anesthesia, outpatient surgery
Medical subject headings: Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spontaneous ventilationOther
The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
Pressure support ventilationDevice
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 ventilationDevice
The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.

Study groups in NCT03235817
Study group	Role	What they receive
Spontaneous ventilation	Experimental	Not described Receives: Other: Spontaneous ventilation
Pressure support ventilation	Experimental	Not described Receives: Device: Pressure support ventilation
Pressure control ventilation	Active comparator	Not described Receives: Device: Pressure control ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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
Measured: up to 45 minutes

Secondary outcomes (3)

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.
Measured: Up to 45 minutes
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.
Measured: 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.
Measured: Up to 45 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Jul 2010

First posted1 Aug 2017
Study startDec 2009
Primary completionJul 2010
Study completionJul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for VentilationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03235817
Sponsor's protocol ID: IRB00011814
Status last verified: Apr 2018
First submitted: 8 Feb 2013
Last updated: 18 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

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.
PubMed 4003736

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Potential Impact of the Use of the Application VentilO
Mechanical Ventilation Complication
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VentilO Prospective Study
Mechanical Ventilation Complication, Respiratory Acidosis
RecruitingObservational study
Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
Thoracic, Surgery
Active, not recruiting
Prevalence and Clinical Impact of Airway Opening Pressure in Post-Cardiac Surgery Patients
Cardiac Surgery, Mechanical Ventilation After Surgery
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock

All Ventilation trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Different Ventilation Strategies in Infants Using the Proseal™ Laryngeal Mask Airway
ClinicalTrials.gov ID: NCT03235817
Acronym / sponsor ID: IRB00011814
Conditions: Ventilation
Keywords: Proseal™ LMA, infants, ventilation, general anesthesia, outpatient surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Wake Forest UniversityUniversity, hospital or other
Study start: Dec 2009
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 1 Aug 2017 (actual)
Results: Posted 16 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

This study will attempt to determine whether pressure support ventilation improves ventilation in infants undergoing outpatient surgery.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Spontaneous ventilation	Experimental	Other: Spontaneous ventilation
Pressure support ventilation	Experimental	Device: Pressure support ventilation
Pressure control ventilation	Active comparator	Device: Pressure control ventilation

Who may qualify

Ages: 1 month to 11 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

ASA (American Society of Anesthesiologists) physical classification of 1 or 2
Outpatient surgical procedures
Surgical procedure anticipated to be < 90 minutes
Subject age of 1 - 11 months (inclusive)

Key exclusion criteria (6 listed)

Inpatient- Such individuals may have underlying disease processes which puts them at an increased risk under general anesthesia for hypoventilation
ASA physical classification of 3, 4 or E
Premature infants or infants < 44 weeks post-conceptual age
Risk of aspiration- Intubation with an endotracheal tube may be required for general anesthesia.
Patients with malignant hyperthermia or family history of malignant hyperthermia- Administration of inhalational agents for general anesthesia is contraindicated.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Spontaneous ventilationThe patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.	Other	Spontaneous ventilation
Pressure support ventilationThe 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.	Device	Pressure support ventilation
Pressure control ventilationThe patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.	Device	Pressure control ventilation

Primary outcome

Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.
Time frame: 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
Time frame: 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
Time frame: up to 45 minutes
Mean values of ETCO2 and TV between 5 and 45 minutes compared between the PSV and PCV groups

3 secondary outcomes

Mean Values of Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.
Time frame: Up to 45 minutes
Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.
Time frame: Up to 45 minutes
Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.
Time frame: Up to 45 minutes

Results and safety

Results posted to the registry on 16 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spontaneous Ventilation	13	10
Pressure Support Ventilation	13	12
Pressure Control Ventilation	13	11

Primary outcome: Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.

Time frame: Up to 45 minutes. Mean (Standard Deviation). Unit: cc/kg

Measure	Spontaneous Ventilation n = 10	Pressure Support Ventilation n = 12
Mean Values of Tidal Volume	4.5 (.3)	7 (.5)
Mean Values of End-Tidal Carbon Dioxide	51.8 (2.9)	49 (1.5)

Primary outcome: Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups

Time frame: Up to 45 minutes. Mean (Standard Deviation). Unit: cc/kg

Measure	Spontaneous Ventilation n = 10	Pressure Control Ventilation n = 11
ETCO2	51.8 (2.9)	48.3 (1.6)
TV	4.5 (0.3)	7.0 (0.4)

Primary outcome: Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups

Time frame: up to 45 minutes. Mean (Standard Deviation). Unit: cc/kg

Measure	Pressure Support Ventilation n = 12	Pressure Control Ventilation n = 11
ETCO2	49.0 (1.5)	48.3 (1.6)
TV	7.0 (0.5)	7.0 (0.4)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spontaneous Ventilation	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Pressure Support Ventilation	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Pressure Control Ventilation	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 4003736Brain 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.

Related trials for Ventilation

Active, not recruitingObservational study
Potential Impact of the Use of the Application VentilO
Mechanical Ventilation Complication
Active, not recruiting
VentilO Prospective Study
Mechanical Ventilation Complication, Respiratory Acidosis
RecruitingObservational study
Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
Thoracic, Surgery
Active, not recruiting
Prevalence and Clinical Impact of Airway Opening Pressure in Post-Cardiac Surgery Patients
Cardiac Surgery, Mechanical Ventilation After Surgery
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Templeton, M.D. principal investigator

Wake Forest

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Spontaneous ventilation and Pressure support ventilation in people with Ventilation, run by Wake Forest University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. (time frame: Up to 45 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03235817, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.