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

NCT02385305 | Withdrawn

• 1 other identifier: 2014P001841
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia

Keywords

Pressure support ventilation; respiratory drive; Physiology

Outcome Measures

Primary Outcomes (1)

• 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

  0, 5, 10, 15, 20, 25, 30 and 35 min after the initiation of PSV

Secondary Outcomes (2)

• Respiratory rate measured by Respiratory monitor

  0, 5, 10, 15, 20, 25, 30 and 35 min after the initiation of PSV

• Expiratory tidal volume measured by Respiratory monitor

  0, 5, 10, 15, 20, 25, 30 and 35 min after the initiation of PSV

Study Arms (1)

Pressure support ventilation

OTHER

Usual anesthesia management

Device: Pressure support ventilation by anesthesia machine (Apollo, Dräger)

Interventions

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.

Pressure support ventilation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Related Publications (2)

• 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.

  PMID: 18456641 BACKGROUND

• Yamanaka T, Sadikot RT. Opioid effect on lungs. Respirology. 2013 Feb;18(2):255-62. doi: 10.1111/j.1440-1843.2012.02307.x.

  PMID: 23066838 BACKGROUND

Study Officials

• Yandong Jian, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: March 11, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 18, 2017

Record last verified: 2017-01