Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

22 juli 2019 uppdaterad av: Edward O'Brien, University of California, San Diego
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.

Studieöversikt

Status

Avslutad

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

32

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • California
      • La Jolla, California, Förenta staterna, 92037
        • UCSD Thornton Hopsital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Measure the collective differences in end-tidal carbon dioxide upon arrival in the ICU between mechanical ventilation and hand-ventilation
Tidsram: Baseline
Baseline
Measure the collective differences in pulmonary arterial pressures upon arrival in the ICU between mechanical ventilation and hand-ventilation
Tidsram: Baseline
Baseline

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Edward O'Brien, MD, University of California, San Diego

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 augusti 2015

Primärt slutförande (Faktisk)

1 juni 2016

Avslutad studie (Faktisk)

1 juni 2016

Studieregistreringsdatum

Först inskickad

5 februari 2016

Först inskickad som uppfyllde QC-kriterierna

11 april 2016

Första postat (Uppskatta)

15 april 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 juli 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 juli 2019

Senast verifierad

1 juli 2019

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • IRB# 150836

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera