Intraoperative VentilationNCT00966433

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

A study testing Spontaneous ventilation and Pressure support Ventilation in people with Intraoperative Ventilation, run by Wake Forest University Health Sciences 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

Search all trials

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 children under general anesthesia. Read more about this study

Who is it for?: Ages 12 months to 5 years
Conditions the study is for: Intraoperative Ventilation
What is being tested?: Spontaneous ventilation and Pressure support Ventilation
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteUnited States
Study dates: Aug 2009to Oct 2009
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 12 months to 5 years
All sexes
No healthy volunteers
Child

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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.

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™ 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.

Conditions: Intraoperative Ventilation
Being tested: Spontaneous ventilation, Pressure support Ventilation, Pressure control ventilation
Keywords: Proseal™ LMA, children, ventilation, general anesthesia, Children under general anesthesia for 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 ventilationProcedure or surgery
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 NCT00966433
Study group	Role	What they receive
Spontaneous ventilation	Experimental	Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation. Receives: Procedure: Spontaneous ventilation
Pressure support ventilation	Experimental	Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA. Receives: Device: Pressure support Ventilation
Pressure control ventilation	Active comparator	Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA. Receives: Device: Pressure control ventilation

What is being measured

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

Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.
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
Measured: up to 90 minutes
Differences Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.
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
Measured: up to 90 minutes
Mean Values of ETCO2 in SV and PCV Groups
Mean Values of ETCO2 in SV and PCV groups reported in mmHg
Measured: up to 90 minutes
Mean Tidal Volume Values Compared Between SV and PCV Groups
Mean Tidal Volume Values compared between SV and PCV Groups. Measured in mL/kg
Measured: up to 90 minutes
Mean Values of ETCO2 Between the PSV and PCV Groups
Mean Values of ETCO2 between the PSV and PCV Groups. Measured in mmHg
Measured: up to 90 minutes
Mean Values of Tidal Volume Between the PSV and PCV Groups
Mean Values of Tidal Volume Between the PSV and PCV Groups. Measured in mL/kg
Measured: up to 90 minutes

Secondary outcomes (3)

Differences in Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.
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.
Measured: up to 90 minutes
Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.
Measured: up to 90 minutes
Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.
Measured: up to 90 minutes

Timeline

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

Aug 2009Oct 2009

First posted27 Aug 2009 (estimated)
Study startAug 2009
Primary completionOct 2009
Study completionOct 2009

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 (12)Papers the sponsor has linked to this study.
Other trials for Intraoperative VentilationStudies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
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: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00966433
Sponsor's protocol ID: IRB00009452
Status last verified: Nov 2018
First submitted: 25 Aug 2009
Last updated: 5 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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
Mason DG, Bingham RM. The laryngeal mask airway in children. Anaesthesia. 1990 Sep;45(9):760-3. doi: 10.1111/j.1365-2044.1990.tb14449.x.
PubMed 2100990
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. doi: 10.1093/bja/aeh238. Epub 2004 Aug 6.
PubMed 15298876
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.
PubMed 18166745
Bagshaw O. The size 1.5 laryngeal mask airway (LMA) in paediatric anaesthetic practice. Paediatr Anaesth. 2002 Jun;12(5):420-3. doi: 10.1046/j.1460-9592.2002.00887.x.
PubMed 12060328
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.
PubMed 18647269
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. doi: 10.1111/j.1460-9592.2005.01788.x.
PubMed 16490094
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.
PubMed 15920181
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. doi: 10.1111/j.1365-2044.1996.tb14968.x.
PubMed 8984875
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. doi: 10.1046/j.1460-9592.2001.00746.x.
PubMed 11696145
Lopez 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. doi: 10.1046/j.1460-9592.1999.00404.x.
PubMed 10597550
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. doi: 10.1213/01.ane.0000287674.64086.f1.
PubMed 18042854

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

Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Recruiting
PROtective Ventilation With FLOW-Controlled Ventilation
Postoperative Pulmonary Complications (PPCs), Feasibility Studies
RecruitingObservational study
VC-AF vs FCV in Obese Patients Undergoing Laparoscopic Surgery
Anesthesia, Mechanical Ventilation
Recruiting
Compliance-Guided Abdominal Wall Closure Strategy in Large Ventral Hernia Repair
Hernia, Ventral, Hernia Incisional
Recruiting
Impact of Intraoperative Oxygenation Practices on Patient Outcomes
Surgeries Undergoing General Anesthesia

All Intraoperative Ventilation trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Different Ventilation Strategies in Children Using the Proseal™ Laryngeal Mask Airway
ClinicalTrials.gov ID: NCT00966433
Acronym / sponsor ID: IRB00009452
Conditions: Intraoperative Ventilation
Keywords: Proseal™ LMA, children, ventilation, general anesthesia, Children under general anesthesia for outpatient surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Study start: Aug 2009
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 27 Aug 2009 (estimated)
Results: Posted 13 Nov 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 children under general anesthesia.

Detailed description

This study will attempt to determine whether pressure support ventilation improves ventilation in children 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	Procedure: Spontaneous ventilationPt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.
Pressure support ventilation	Experimental	Device: Pressure support VentilationPt's will receive positive pressure assistance with each spontaneous breath through the PLMA.
Pressure control ventilation	Active comparator	Device: Pressure control ventilationPt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA.

Who may qualify

Ages: 12 months to 5 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (5 listed)

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

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.	Procedure or surgery	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

Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.
Time frame: 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
Differences Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.
Time frame: 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
Mean Values of ETCO2 in SV and PCV Groups
Time frame: up to 90 minutes
Mean Values of ETCO2 in SV and PCV groups reported in mmHg
Mean Tidal Volume Values Compared Between SV and PCV Groups
Time frame: up to 90 minutes
Mean Tidal Volume Values compared between SV and PCV Groups. Measured in mL/kg
Mean Values of ETCO2 Between the PSV and PCV Groups
Time frame: up to 90 minutes
Mean Values of ETCO2 between the PSV and PCV Groups. Measured in mmHg
Mean Values of Tidal Volume Between the PSV and PCV Groups
Time frame: up to 90 minutes
Mean Values of Tidal Volume Between the PSV and PCV Groups. Measured in mL/kg

3 secondary outcomes

Differences in Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.
Time frame: up to 90 minutes
Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.
Time frame: up to 90 minutes
Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.
Time frame: up to 90 minutes

Results and safety

Results posted to the registry on 13 Nov 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	11	10
Pressure Support Ventilation	11	10
Pressure Control Ventilation	11	11

Primary outcome: Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.

Time frame: up to 90 minutes. Mean (Standard Deviation). Unit: mmHg

Measure	Spontaneous Ventilation n = 10	Pressure Support Ventilation n = 10
Value	55.2 (5.5)	47 (6)

Spontaneous Ventilation vs Pressure Support Ventilation: Mean Difference (Final Values): -8.2 (95% CI -13.61 to -2.79), p = .0051, t-test, 2 sided

Primary outcome: Differences Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.

Time frame: up to 90 minutes. Mean (Standard Deviation). Unit: mL/kg

Measure	Spontaneous Ventilation n = 10	Pressure Support Ventilation n = 10
Value	4.0 (.8)	7.6 (.5)

Spontaneous Ventilation vs Pressure Support Ventilation: Mean Difference (Final Values): 3.6 (95% CI 2.97 to 4.23), p = .0001, t-test, 2 sided

Primary outcome: Mean Values of ETCO2 in SV and PCV Groups

Time frame: up to 90 minutes. Mean (Standard Deviation). Unit: mmHg

Measure	Spontaneous Ventilation n = 10	Pressure Control Ventilation n = 11
Value	55.2 (5.5)	43.1 (0.8)

Primary outcome: Mean Tidal Volume Values Compared Between SV and PCV Groups

Time frame: up to 90 minutes. Mean (Standard Deviation). Unit: mL/kg

Measure	Spontaneous Ventilation n = 10	Pressure Control Ventilation n = 11
Value	4.0 (0.8)	7.6 (0.2)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 90 minutes. Other adverse events reported at 5% 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 10 (0%)	0 of 10 (0%)	0 of 10
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 5 Dec 2018.
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.
Background: PubMed 2100990Mason DG, Bingham RM. The laryngeal mask airway in children. Anaesthesia. 1990 Sep;45(9):760-3. doi: 10.1111/j.1365-2044.1990.tb14449.x.
Background: PubMed 15298876Shimbori 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. doi: 10.1093/bja/aeh238. Epub 2004 Aug 6.
Background: PubMed 18166745Lardner 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.
Background: PubMed 12060328Bagshaw O. The size 1.5 laryngeal mask airway (LMA) in paediatric anaesthetic practice. Paediatr Anaesth. 2002 Jun;12(5):420-3. doi: 10.1046/j.1460-9592.2002.00887.x.
Background: PubMed 18647269Licina 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.
Background: PubMed 16490094Wheeler 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. doi: 10.1111/j.1460-9592.2005.01788.x.
Background: PubMed 15920181Goldmann 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.
Background: PubMed 8984875Lopez-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. doi: 10.1111/j.1365-2044.1996.tb14968.x.
Background: PubMed 11696145Keidan 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. doi: 10.1046/j.1460-9592.2001.00746.x.
Background: PubMed 10597550Lopez 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. doi: 10.1046/j.1460-9592.1999.00404.x.
Background: PubMed 18042854Garcia-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. doi: 10.1213/01.ane.0000287674.64086.f1.
Individual participant dataSharing planned: No

Related trials for Intraoperative Ventilation

Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Recruiting
PROtective Ventilation With FLOW-Controlled Ventilation
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RecruitingObservational study
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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 W Templeton, M.D. principal investigator

Wake Forest University Health Sciences

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 Intraoperative Ventilation, run by Wake Forest University Health Sciences 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 5 inclusion and 5 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 5 Dec 2018. 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 13 Nov 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?

Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. (time frame: up to 90 minutes). The study lists 6 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 NCT00966433, which also lists 12 linked publications.

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 5 Dec 2018.