- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01522222
Study to Determine if Using Ventilation During Open Heart Surgery Improves Lung Outcomes (PEEP)
Effect of Continuous Mechanical Ventilation During Cardiopulmonary Bypass on The Lung Mechanics: A Prospective Evaluation
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is a prospective, randomized, blinded study with a control group. The study group will receive mechanical ventilatory support during CBB, which consists of a preset/predetermined tidal volume, respiratory rate, positive pressure at the end of expiration and FIO2. The control group will receive CPB without additional mechanical ventilatory support during surgery, which at present is the standard of care.
The difference between the study and the control group will occur during the time the heart is arrested and the lungs, under present standard of care, are no longer ventilated. It is at this point in time that those in the study group will continue to receive ventilation, intermittent positive pressure ventilation, while their heart is arrested. The subjects will have their lungs ventilated six times per minute with a tidal volume equal to 7-10 milliliters per kilogram. This range, when combined with a consistent PEEP of 5cm of water pressure, will allow for the peak inspiratory pressure to be maintained at or below 40cm of water pressure. In addition, the FIO2 will remain consistent at the same level that was needed to maintain the pulse oximetry at 94% as well as the end-tidal CO2 at 35mmHg. The values mentioned for this study have been chosen based on not only investigator preference, but also on what is considered "minimally necessary" to prevent atelectasis. Multiple studies have been done utilizing PEEP at 5 and 10 cm of water pressure. With the exception of the potential for mechanical ventilation during the CBP, the care of the subject, regardless of the group randomized into, will be the same. We will in all other aspects continue to utilize the current standard of care.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Wisconsin
-
Green Bay, Wisconsin, Förenta staterna, 54311
- Aurora BayCare Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- any patient of any gender, any age with known coronary artery disease that will undergo elective Coronary Artery Bypass Grafting (CABG) and will require CPB as part of his/her operative technique.
Exclusion Criteria:
- documented ejection fraction (either by echocardiogram or by cardiac catheterization) equal to or below 20%
- patients with cardiac valvular disease
- patients with a spirometry measurement that demonstrates an FEV1/FVC ratio below 60%
- patients with chronic renal failure who require dialysis or
- those who have experienced an allergic reaction to anesthesia in the past
- patients with a history of lung infiltrate on chest X-ray prior to surgery or a history of asthma
- Women who are pregnant are excluded
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Control
half of the study subjects will receive standard of care during their open heart surgery.
|
|
|
Experimentell: Treatment
half of the study subjects will receive the prescribed ventilatory support during open heart surgery.
|
Those in the treatment group will receive ventilation, intermittent positive pressure ventilation, while their heart is arrested.
The subjects will have their lungs ventilated six times per minute with a tidal volume equal to 7-10 milliliters per kilogram.
This range, when combined with a consistent PEEP of 5cm of water pressure, will allow for the peak inspiratory pressure to be maintained at or below 40cm of water pressure.
In addition, the FIO2 will remain consistent at the same level that was needed to maintain the pulse oximetry at 94% as well as the end-tidal CO2 at 35mmHg.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Post-surgical lung function, compliance, tissue oxygenation, and radiographic changes indicative of atelectasis.
Tidsram: During in-patient stay
|
Determination if ventilation during surgery improves post-surgical lung function, compliance, tissue oxygenation, and radiographic changes indicative of atelectasis.
|
During in-patient stay
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Raul Mendoza-Ayala, MD, Aurora Health Care
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PEEP
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