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

January 15, 2017 updated by: Yandong Jiang, Massachusetts General Hospital

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0, 5, 10, 15, 20, 25, 30 and 35 min after the initiation of PSV

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
expiratory tidal volume (ml): this assessment relies on multiple measurements over time and the Time Frame includes multiple time points
0, 5, 10, 15, 20, 25, 30 and 35 min after the initiation of PSV

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Yandong Jian, MD, PhD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

December 1, 2014

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 15, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014P001841

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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