AnesthesiaNCT02385305
The Effect of Pressure Support Ventilation on Spontaneous Breathing in Anesthetized Subjects
A study testing Pressure support ventilation by anesthesia machine (Apollo, Dräger) in people with Anesthesia, run by Massachusetts General Hospital.
Trial summary
The aim of this prospective study is to determine the effect of pressure support ventilation (PSV) on minute alveolar ventilation (MAV) and end-tidal carbon dioxide (ETCO2) in anesthetized spontaneously breathing subjects by observing alterations of respiratory rate (RR), expiratory tidal volume, MAV and ETCO2 at… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Pressure support ventilation by anesthesia machine (Apollo, Dräger)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status classification I or II
- Expected to be ventilated with a laryngeal mask airway (LMA)
- Expected to have anesthesia titrated to insure continued spontaneous breathing
Who cannot join
- Patients whose surgery will last less than 70 minutes
- Obese patients with BMI 30 kg/m2 or higher
- Patients who will have thoracic or abdominal surgery
- Patients with gastro-esophageal reflux disease
- Patients who will needed muscle relaxants or are expected to require controlled ventilation during surgery
- Patients with chronic obstructive pulmonary disease or asthma
Show all 12Show fewer
- Patients with neuromuscular disease or presenting with increased intracranial pressure
- Patients with major cardiovascular disease, or cerebral vascular disease
- Abnormal vital signs on the day of admission for surgery [heart rate (HR); >100 bpm or <40 bpm, Noninvasive blood pressure (NIBP); >180/100 mmHg or <90/60 mmHg or transcutaneous oxyhemoglobin saturation (SpO2); <94%] that are not correctable with his or her routine medication or commonly used pre-operative medication
- Pregnant women and women less than one month post-partum. Pregnancy will be ruled out by careful history and physical examination. If history is equivocal, the subject will be excluded unless a negative pregnancy test is obtained
- Emergent cases
- Chronic opioid use
About this study
Official title: The Effect of Pressure Support Ventilation on Minute Alveolar Ventilation and End-tidal Carbon Dioxide in Anesthetized Spontaneously Breathing Subjects
The aim of this prospective study is to determine the effect of pressure support ventilation (PSV) on minute alveolar ventilation (MAV) and end-tidal carbon dioxide (ETCO2) in anesthetized spontaneously breathing subjects by observing alterations of respiratory rate (RR), expiratory tidal volume, MAV and ETCO2 at variable levels of pressure support.
Read the detailed description
Anesthesia induction will be performed with usual anesthetics without any opioids and followed by the placement of a laryngeal mask airway. Optimal anesthesia level will be maintained with inhalation anesthesia so as to obtain a bispectral index of 30 to 50. Subjects will be ventilated with controlled mechanical ventilation (CMV) by the anesthesia ventilator until the presence of spontaneous breathing can be affirmed. A carbon dioxide/flow sensor (Adult Combined CO2/Flow Sensor; Novametrix medical systems INC., Wallingford, CT) will be placed between the LMA and the breathing circuit. The sensor will be connected to a noninvasive cardiac output monitor (NICO; Noninvasive Cardiopulmonary management System, model 7300; Respironics Corp., Murrysville, PA). NICO data (end-tidal CO2 (ETCO2), tidal volume and flow waveforms) will be recorded and stored on a personnel computer. At the start of surgery, the anesthesia care provider will administer opioids to control nociceptive stimuli from surgery. Figure 2 shows the procedural course of the study. Once spontaneous breathing is observed, PSV will be applied with pressure support (PS) of 3, 8, 13 and 18 cmH2O in this order, with slope of 1.0 second and no PEEP. The fraction of inspired oxygen will be titrated to achieve SpO2 over 98%. Five minutes will be allowed to achieve equilibrium at each PS level after which an additional recording of one minute of data will be obtained. Once the PSV is completed at 18 cmH2O, ventilation will be carried out in reverse order of PS; 13, 8 and 3 cmH2O of PS. If at any point in the course of the study the subjects ETCO2 is higher than 60 mmHg, obvious body motion is observed or abnormal vital signs [NIBP; >160/90 mmHg or <80/50 mmHg, HR; >100 mmHg or <40 mmHg, SpO2; <94% at a given fraction of inspired O2] occur, the study will be terminated and routine care will be provided.
- Conditions
- Anesthesia
- Being tested
- Pressure support ventilation by anesthesia machine (Apollo, Dräger)
- Keywords
- Pressure support ventilation, respiratory drive, Physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure support ventilation by anesthesia machine (Apollo, Dräger)Device
Pressure support ventilation will be applied by anesthesia machine (Apollo, Dräger) with pressure support (PS) of 3, 8, 13 and 18 cmH2O in this order, with slope of 1.0 second and no PEEP. The fraction of inspired oxygen will be titrated to achieve SpO2 over 98%. Five minutes will be allowed to achieve equilibrium at each PS level after which an additional recording of one minute of data will be obtained. Once the Pressure support ventilation is completed at 18 cmH2O, ventilation will be carried out in reverse order of PS; 13, 8 and 3 cmH2O of PS.
| Study group | Role | What they receive |
|---|---|---|
| Pressure support ventilation | Other | Usual anesthesia management Receives: Device: Pressure support ventilation by anesthesia machine (Apollo, Dräger) |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-tidal carbon dioxide measured by Capnograph monitor
end-tidal carbon dioxide (mmHg): this assessment relies on multiple measurements over time and the Time Frame includes multiple time points
Measured: 0, 5, 10, 15, 20, 25, 30 and 35 min after the initiation of PSV
Secondary outcomes (2)
Respiratory rate measured by Respiratory monitor
respiratory rate (breath/min): this assessment relies on multiple measurements over time and the Time Frame includes multiple time points
Measured: 0, 5, 10, 15, 20, 25, 30 and 35 min after the initiation of PSV
Expiratory tidal volume measured by Respiratory monitor
expiratory tidal volume (ml): this assessment relies on multiple measurements over time and the Time Frame includes multiple time points
Measured: 0, 5, 10, 15, 20, 25, 30 and 35 min after the initiation of PSV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yandong Jiang, Massachusetts General Hospital
- Investigators
- Yandong Jian, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385305
- Sponsor's protocol ID
- 2014P001841
- Status last verified
- Jan 2017
- First submitted
- 1 Dec 2014
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Pattinson KT. Opioids and the control of respiration. Br J Anaesth. 2008 Jun;100(6):747-58. doi: 10.1093/bja/aen094. Epub 2008 May 1.
PubMed 18456641Yamanaka T, Sadikot RT. Opioid effect on lungs. Respirology. 2013 Feb;18(2):255-62. doi: 10.1111/j.1440-1843.2012.02307.x.
PubMed 23066838
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pressure Support Ventilation on Minute Alveolar Ventilation and End-tidal Carbon Dioxide in Anesthetized Spontaneously Breathing Subjects
- ClinicalTrials.gov ID
- NCT02385305
- Acronym / sponsor ID
- 2014P001841
- Conditions
- Anesthesia
- Keywords
- Pressure support ventilation, respiratory drive, Physiology
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this prospective study is to determine the effect of pressure support ventilation (PSV) on minute alveolar ventilation (MAV) and end-tidal carbon dioxide (ETCO2) in anesthetized spontaneously breathing subjects by observing alterations of respiratory rate (RR), expiratory tidal volume, MAV and ETCO2 at variable levels of pressure support.
Detailed description
Anesthesia induction will be performed with usual anesthetics without any opioids and followed by the placement of a laryngeal mask airway. Optimal anesthesia level will be maintained with inhalation anesthesia so as to obtain a bispectral index of 30 to 50. Subjects will be ventilated with controlled mechanical ventilation (CMV) by the anesthesia ventilator until the presence of spontaneous breathing can be affirmed. A carbon dioxide/flow sensor (Adult Combined CO2/Flow Sensor; Novametrix medical systems INC., Wallingford, CT) will be placed between the LMA and the breathing circuit. The sensor will be connected to a noninvasive cardiac output monitor (NICO; Noninvasive Cardiopulmonary management System, model 7300; Respironics Corp., Murrysville, PA). NICO data (end-tidal CO2 (ETCO2), tidal volume and flow waveforms) will be recorded and stored on a personnel computer. At the start of surgery, the anesthesia care provider will administer opioids to control nociceptive stimuli from surgery. Figure 2 shows the procedural course of the study. Once spontaneous breathing is observed, PSV will be applied with pressure support (PS) of 3, 8, 13 and 18 cmH2O in this order, with slope of 1.0 second and no PEEP. The fraction of inspired oxygen will be titrated to achieve SpO2 over 98%. Five minutes will be allowed to achieve equilibrium at each PS level after which an additional recording of one minute of data will be obtained. Once the PSV is completed at 18 cmH2O, ventilation will be carried out in reverse order of PS; 13, 8 and 3 cmH2O of PS. If at any point in the course of the study the subjects ETCO2 is higher than 60 mmHg, obvious body motion is observed or abnormal vital signs [NIBP; >160/90 mmHg or <80/50 mmHg, HR; >100 mmHg or <40 mmHg, SpO2; <94% at a given fraction of inspired O2] occur, the study will be terminated and routine care will be provided.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pressure support ventilation | Other | Device: Pressure support ventilation by anesthesia machine (Apollo, Dräger)Usual anesthesia management |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status classification I or II
- Expected to be ventilated with a laryngeal mask airway (LMA)
- Expected to have anesthesia titrated to insure continued spontaneous breathing
Key exclusion criteria (12 listed)
- Patients whose surgery will last less than 70 minutes
- Obese patients with BMI 30 kg/m2 or higher
- Patients who will have thoracic or abdominal surgery
- Patients with gastro-esophageal reflux disease
- Patients who will needed muscle relaxants or are expected to require controlled ventilation during surgery
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 |
|---|---|---|
| Pressure support ventilation by anesthesia machine (Apollo, Dräger)Pressure support ventilation will be applied by anesthesia machine (Apollo, Dräger) with pressure support (PS) of 3, 8, 13 and 18 cmH2O in this order, with slope of 1.0 second and no PEEP. The fraction of inspired oxygen will be titrated to achieve SpO2 over 98%. Five minutes will be allowed to achieve equilibrium at each PS level after which an additional recording of one minute of data will be obtained. Once the Pressure support ventilation is completed at 18 cmH2O, ventilation will be carried out in reverse order of PS; 13, 8 and 3 cmH2O of PS. | Device | Pressure support ventilation |
Primary outcome
End-tidal carbon dioxide measured by Capnograph monitor
Time frame: 0, 5, 10, 15, 20, 25, 30 and 35 min after the initiation of PSV
end-tidal carbon dioxide (mmHg): this assessment relies on multiple measurements over time and the Time Frame includes multiple time points
2 secondary outcomes
Respiratory rate measured by Respiratory monitor
Time frame: 0, 5, 10, 15, 20, 25, 30 and 35 min after the initiation of PSV
Expiratory tidal volume measured by Respiratory monitor
Time frame: 0, 5, 10, 15, 20, 25, 30 and 35 min after the initiation of PSV
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Background: PubMed 18456641Pattinson KT. Opioids and the control of respiration. Br J Anaesth. 2008 Jun;100(6):747-58. doi: 10.1093/bja/aen094. Epub 2008 May 1.
- Background: PubMed 23066838Yamanaka T, Sadikot RT. Opioid effect on lungs. Respirology. 2013 Feb;18(2):255-62. doi: 10.1111/j.1440-1843.2012.02307.x.
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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.
Yandong Jian, MD, PhD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Pressure support ventilation by anesthesia machine (Apollo, Dräger) in people with Anesthesia, run by Massachusetts General Hospital.
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 3 inclusion and 12 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: withdrawn, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
End-tidal carbon dioxide measured by Capnograph monitor (time frame: 0, 5, 10, 15, 20, 25, 30 and 35 min after the initiation of PSV). 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 NCT02385305, which also lists 2 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 18 Jan 2017.