Effect of Mode of Transport Ventilation on Respiratory Parameters After Cardiac Surgery

NCT02740075 | Completed

• 1 other identifier: IRB# 150836
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

After cardiac surgery patients are transported from the operating room (OR) to the intensive care unit (ICU) while intubated. Two principal methods of oxygenation and ventilation are used: (1) a transport ventilator or (2) a Mapleson Bag-Mask hand ventilating circuit. The choice of method is largely determined by the preference of the the anesthesiologist who is transporting the patient. The investigators postulate that the choice of either method might alter respiratory and hemodynamic parameters felt to be important for the immediate management of post-cardiac surgery patients. The investigators will prospectively record end-tidal carbon dioxide (ETCO2) (primary end-point) and change in minute volume, heart rate (HR), Blood pressure (BP), pulmonary artery (PA) pressures and cardiac output during transportation and upon arrival in the ICU. All of these variables are measured routinely but are not recorded. The investigators will compare patients transported with a ventilator to patients transported with a Mapleson circuit.

Conditions

Complication of Ventilation Therapy

Keywords

Mechanical versus hand ventilation; Transport ventilation

Outcome Measures

Primary Outcomes (2)

• Measure the collective differences in end-tidal carbon dioxide upon arrival in the ICU between mechanical ventilation and hand-ventilation

  Baseline

• Measure the collective differences in pulmonary arterial pressures upon arrival in the ICU between mechanical ventilation and hand-ventilation

  Baseline

Study Arms (2)

Hand-ventilated

This group will be transported from the operating room to the intensive care unit with the anesthesia provider ventilating the patient by hand via Mapleson circuit and supplemental oxygen. Vital signs and end-tidal carbon dioxide will be monitored and recorded by one of the investigators. The anesthesia provider will be blinded to the end-tidal carbon dioxide levels and respiratory rate.

Mechanically ventilated

This group will be transported from the operating room to the intensive care unit with the patient being ventilated by a transport ventilator with controlled tidal volume, respiratory rate, and positive end-expiratory pressure. Vital signs and end-tidal carbon dioxide will be monitored and recorded by one of the investigators.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All subjects will have just undergone cardiac surgery, are intubated, and are being transported to the ICU with either method of ventilation. Prospective research subjects will be identified from the list of patients scheduled for surgery on any given day. This list is published daily on a screen outside of the pre-operative area which is accessible to the public. Identifying prospective research subjects will not require access to medical record or review of private information.

You may qualify if:

• Adults scheduled for elective cardiac surgery.
• No known pulmonary disease prior to surgery.

You may not qualify if:

• Patients who refuse to participate, patients under the age of 18, groups with known cognitive impairment, patients who are unable to consent or institutionalized individuals.
• Patients who are not expected to remain intubated after cardiac surgery.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Thornton Hopsital

La Jolla, California, 92037, United States

Location

Related Publications (3)

• Schwebel C, Clec'h C, Magne S, Minet C, Garrouste-Orgeas M, Bonadona A, Dumenil AS, Jamali S, Kallel H, Goldgran-Toledano D, Marcotte G, Azoulay E, Darmon M, Ruckly S, Souweine B, Timsit JF; OUTCOMEREA Study Group. Safety of intrahospital transport in ventilated critically ill patients: a multicenter cohort study*. Crit Care Med. 2013 Aug;41(8):1919-28. doi: 10.1097/CCM.0b013e31828a3bbd.

  PMID: 23863225 BACKGROUND

• Gillman L, Leslie G, Williams T, Fawcett K, Bell R, McGibbon V. Adverse events experienced while transferring the critically ill patient from the emergency department to the intensive care unit. Emerg Med J. 2006 Nov;23(11):858-61. doi: 10.1136/emj.2006.037697.

  PMID: 17057138 BACKGROUND

• Warren J, Fromm RE Jr, Orr RA, Rotello LC, Horst HM; American College of Critical Care Medicine. Guidelines for the inter- and intrahospital transport of critically ill patients. Crit Care Med. 2004 Jan;32(1):256-62. doi: 10.1097/01.CCM.0000104917.39204.0A.

  PMID: 14707589 BACKGROUND

Study Officials

• Edward O'Brien, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Chief of Critical Care

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: April 15, 2016
• Study Start: August 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

US (1)