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Trial record 12 of 577 for:    CARBON DIOXIDE AND anesthesia

The Effect of Pressure Support Ventilation on Spontaneous Breathing in Anesthetized Subjects

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ClinicalTrials.gov Identifier: NCT02385305
Recruitment Status : Withdrawn
First Posted : March 11, 2015
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Yandong Jiang, Massachusetts General Hospital

Brief 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 variable levels of pressure support.

Condition or disease Intervention/treatment Phase
Anesthesia Device: Pressure support ventilation by anesthesia machine (Apollo, Dräger) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Effect of Pressure Support Ventilation on Minute Alveolar Ventilation and End-tidal Carbon Dioxide in Anesthetized Spontaneously Breathing Subjects
Study Start Date : March 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Pressure support ventilation
Usual anesthesia management
Device: 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Respiratory rate measured by Respiratory monitor [ Time Frame: 0, 5, 10, 15, 20, 25, 30 and 35 min after the initiation of PSV ]
    respiratory rate (breath/min): this assessment relies on multiple measurements over time and the Time Frame includes multiple time points

  2. Expiratory tidal volume measured by Respiratory monitor [ Time Frame: 0, 5, 10, 15, 20, 25, 30 and 35 min after the initiation of PSV ]
    expiratory tidal volume (ml): this assessment relies on multiple measurements over time and the Time Frame includes multiple time points



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ASA physical status classification I or II
  2. Expected to be ventilated with a laryngeal mask airway (LMA)
  3. Expected to have anesthesia titrated to insure continued spontaneous breathing

Exclusion Criteria:

  1. Patients whose surgery will last less than 70 minutes
  2. Obese patients with BMI 30 kg/m2 or higher
  3. Patients who will have thoracic or abdominal surgery
  4. Patients with gastro-esophageal reflux disease
  5. Patients who will needed muscle relaxants or are expected to require controlled ventilation during surgery
  6. Patients with chronic obstructive pulmonary disease or asthma
  7. Patients with neuromuscular disease or presenting with increased intracranial pressure
  8. Patients with major cardiovascular disease, or cerebral vascular disease
  9. 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
  10. 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
  11. Emergent cases
  12. Chronic opioid use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385305


Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Yandong Jian, MD, PhD Massachusetts General Hospital

Publications:
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Responsible Party: Yandong Jiang, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02385305     History of Changes
Other Study ID Numbers: 2014P001841
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Keywords provided by Yandong Jiang, Massachusetts General Hospital:
Pressure support ventilation
respiratory drive
Physiology
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs