Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03255356
Other study ID # 16-081
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 12, 2017
Last updated August 18, 2017
Start date November 1, 2017
Est. completion date December 2017

Study information

Verified date March 2017
Source University Hospital, Caen
Contact Marc-Olivier Fischer, MD, PhD
Phone +33 2 31 06 31 06
Email fischer-mo@chu-caen.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate prospectively ventilatory practices in the perioperative cardiac surgery period.


Description:

This is a International Multicentre Observational Trial on all adult cardiac surgery patients with cardiopulmonary bypass (CPB).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All consecutive cardiac surgery patients with CPB during one predefined period,

- Elective or urgent surgery as defined by EuroSCORE2.

Exclusion Criteria:

- Refusal of consent,

- Pregnant women,

- Age < 18 years,

- Heart transplant, ECLS, ventricular assist

- Emergency or salvage surgery as defined by EuroSCORE2

Study Design


Intervention

Other:
Survey
An anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria.

Locations

Country Name City State
Belgium CUB Erasm, Université libre de Bruxelles Brussels
Brazil Universidade Federal de São Paulo (UNIFESP) Brasil
Czechia General University Hospital Praha
France Caen University Hospital Caen
Germany Klinik für Anästhesiologie und Intensivmedizin Jena
Italy Azienda Ospedaliera Universitaria Pisa
Japan Osaka city University Graduate school of Medecine Osaki
Netherlands VU University Hospital Amsterdam
Norway St Olav University Hospital Trondheim
Poland Wroclaw Medical University Wroclaw

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Countries where clinical trial is conducted

Belgium,  Brazil,  Czechia,  France,  Germany,  Italy,  Japan,  Netherlands,  Norway,  Poland, 

References & Publications (3)

Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082. — View Citation

Güldner A, Kiss T, Serpa Neto A, Hemmes SN, Canet J, Spieth PM, Rocco PR, Schultz MJ, Pelosi P, Gama de Abreu M. Intraoperative protective mechanical ventilation for prevention of postoperative pulmonary complications: a comprehensive review of the role of tidal volume, positive end-expiratory pressure, and lung recruitment maneuvers. Anesthesiology. 2015 Sep;123(3):692-713. doi: 10.1097/ALN.0000000000000754. Review. — View Citation

Lellouche F, Delorme M, Bussières J, Ouattara A. Perioperative ventilatory strategies in cardiac surgery. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):381-95. doi: 10.1016/j.bpa.2015.08.006. Epub 2015 Sep 4. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary incidence of use prophylactic protective mechanical ventilation defined with with low tidal volume (6 to 8 ml / kg based on the ideal body weight) percent 1 day
Secondary incidence of using positive end-expiratory pressure (PEEP)> 5 cmH2O 1 day
Secondary incidence of using at least 2 alveolar lung recruitment manoeuvres percent 1 day
Secondary incidence of using a protective ventilation bundle combining prophylactic protective mechanical ventilation and at least 2 alveolar recruitment manoeuvres percent 1 day
Secondary incidence of postoperative pulmonary complications percent 1 month postoperatively
See also
  Status Clinical Trial Phase
Recruiting NCT06063798 - Respiratory Effects of Flow-Controlled Ventilation and Jet Ventilation in Patients Undergoing Laryngotracheal Surgery N/A
Not yet recruiting NCT05035069 - Efficacy and Safety of Ciprofol Compared to Propofol for Nonintubated General Anesthesia in Patients Undergoing TAVR Phase 4
Completed NCT03861364 - Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose. Phase 4
Completed NCT02711280 - The Effect of Anesthetics on Oxidative Stress and Apoptosis Status in Children N/A
Completed NCT01199471 - Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane N/A
Completed NCT00917033 - Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy Phase 4
Completed NCT00391885 - Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy Phase 4
Completed NCT00552617 - A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971) Phase 2
Completed NCT03705026 - Relationship Between Genetic Polymorphism and Postoperative Nausea and Vomiting in Chinese Han Population
Completed NCT00552929 - A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Caucasian Participants. Part B (P05974) Phase 2
Completed NCT00475215 - Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017) Phase 3
Completed NCT00298831 - Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023) Phase 3
Recruiting NCT03943745 - EEG Changes During Induction of Propofol Anesthesia
Completed NCT03697642 - Nasopharyngeal Airway Guide Nasogastric Tube Placement N/A
Completed NCT04595591 - Observation of Propofol Titration at Different Speeds N/A
Not yet recruiting NCT05841316 - The ED95 Dose of Sugammadex to Reverse Rocuronium-Induced Deep Neuromuscular Block Back to Shallow Neuromuscular Block
Completed NCT04532502 - Impact of Anesthetic Environment the Sex Ratio of the Children of Female Assistants
Completed NCT03330236 - EEG - Guided Anesthetic Care and Postoperative Delirium N/A
Recruiting NCT06205212 - High-flow Nasal Oxygenation During Preoxygenation and Atelectasis N/A
Completed NCT00379613 - Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942) Phase 2