Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 80 of 683 for:    CARBON DIOXIDE AND arterial

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02740075
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Edward O'Brien, University of California, San Diego

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.

Condition or disease
Complication of Ventilation Therapy

Detailed Description:

After cardiac surgery, patients can have poor respiratory function and hemodynamics. The exact cause and contributing factors of this deterioration are not usually known and, often these patients demonstrate normal parameters at the end of surgery, but are significantly altered upon arrival in the ICU. Transportation of patients from the OR to the ICU is a period of significantly less intense monitoring and less well-controlled interventions (for example tidal volume (Vt) is largely arbitrary). Recent evidence suggests that the risk of intra-hospital transportation is significantly higher for ventilated patients than for all other patients. Some of this risk might be mitigated by the mode of ventilation because pulmonary and hemodynamic parameters are rarely measured during transportation. If the method used for ventilation and oxygenation during transport is important in maintaining stability upon presentation to the ICU, clinicians might choose one method over another. This would change clinical practice.

This is a prospective observational study assessing the effect of different modes of transport ventilation on respiratory and hemodynamic parameters on post cardiothoracic (CT) surgery patients admitted to the ICU. It is standard of care to measure peripheral blood CO2 (either end-tidal or arterial), minute volume, heart rate, blood pressure, cardiac output and pulmonary artery pressure for all patients admitted to the ICU after cardiac surgery. The investigators will simply record these values during transport and immediately on arrival in the ICU. At a 2 sided significance level of 0.05, the investigators will enroll 32 patients to detect a minimal difference from baseline ETCO2 of 15% at a power of 0.8.

The investigators will review each subjects medical record to obtain vital sign information and ventilatory parameters. The investigators will obtain individual HIPAA authorization from each subject.

All subjects will have just undergone cardiac surgery are intubated and are being transported to the ICU with either method of ventilation. The patients will be adult (age 18 and over who are competent to give their own consent). They will be recruited prior to surgery according to the inclusion and exclusion criteria listed below. No consideration will be made to gender, race, sexual orientation or national origin.

Layout table for study information
Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Mode of Transport Ventilation on Respiratory Parameters After Cardiac Surgery
Actual Study Start Date : August 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort
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.



Primary Outcome Measures :
  1. Measure the collective differences in end-tidal carbon dioxide upon arrival in the ICU between mechanical ventilation and hand-ventilation [ Time Frame: Baseline ]
  2. Measure the collective differences in pulmonary arterial pressures upon arrival in the ICU between mechanical ventilation and hand-ventilation [ Time Frame: Baseline ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

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): NCT02740075


Locations
Layout table for location information
United States, California
UCSD Thornton Hopsital
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Investigators
Layout table for investigator information
Principal Investigator: Edward O'Brien, MD University of California, San Diego

Publications:
Layout table for additonal information
Responsible Party: Edward O'Brien, Clinical Chief of Critical Care, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02740075    
Other Study ID Numbers: IRB# 150836
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Edward O'Brien, University of California, San Diego:
Mechanical versus hand ventilation
Transport ventilation