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Intraoperative fresh gas flow and ventilation settings in Germany (NO-HARM)

Organizational Data

DRKS-ID:
DRKS00029368
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2023-01-19
Last update in DRKS:
2023-05-15
Registration type:
Prospective

Acronym/abbreviation of the study

NO-HARM

URL of the study

No Entry

Brief summary in lay language

Intraoperative ventilation is indisputable for the patients’ benefit, however, it also presents potential risks not only to the health of the patient being ventilated, but also to the overall public health. Intraoperative ventilation settings are crucial to ensure optimal gas exchange and to avoid complications. Anaesthetic gases are potent greenhouse gases and thus fresh gas flow settings and the choice of the inhalational anesthetic contribute to the overall carbon footprint of hospitals. In order to ensure high quality patient care in the future, anesthesiologists have to question their practices regarding sustainability. Up until now, it is unknown, which intraoperative ventilation and fresh gas flow settings German anesthesiologists routinely use.To ensure anesthesia without imposing harm to the society and patients, it is essential to assess our intraoperative ventilation practice, to identify areas of improvement and to take action accordingly. This study aims at investigating and improving ventilation practices in Germany.

Brief summary in scientific language

Intraoperative ventilation is indisputable for the patients’ benefit, however, it also presents potential risks not only to the health of the patient being ventilated, but also to the overall public health. Commonly used anesthetic gases are potent greenhouse gases and thus, Fresh gas flow (FGF) settings in combination with anesthetic gases, and also the choice of the inhalational anesthetic contribute to the overall carbon footprint of hospitals. On the other hand, intraoperative ventilation settings such as tidal volume (Vt), positive end-expiratory pressure (PEEP) and respiratory rate are crucial pillars to ensure optimal gas exchange and to avoid postoperative complications. Up until now, it is unknown, which intraoperative fresh gas flow, Vts and other ventilation settings German anesthetists routinely use. To ensure anesthesia without imposing harm to the society and patients, it is essential to assess our intraoperative ventilation practice, to identify areas of improvement and to take action accordingly. We aim to perform a nation-wide cross-sectional assessment of intraoperative ventilation parameters, followed by an educational intervention and a follow-up cross-sectional assessment.

Health condition or problem studied

Free text:
intraoperative ventilation
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
All Departments of Anaesthesiology in Germany are invited to participate in this nation-wide cross-sectional assessment of intraoperative ventilation parameters, followed by an educational intervention and a follow-up cross-sectional assessment.

Endpoints

Primary outcome:
FGF in balanced anaesthesia cases, Vt/kg ideal body weigh before and after the educational intervention
Secondary outcome:
Prior and after the educational intervention: Proportional use of desflurane, sevoflurane, isoflurane, nitrous oxide and propofol, proportion of patients ventilated with Vt ≥10 ml/kg ideal body weight, PEEP level, peak inspiratory pressure, driving pressure, end-tidal cabopn dioxide, fraction of inspired oxygen, respiratory rate, use of neuromuscular monitoring, use of temperature monitoring

Study Design

Purpose:
Other
Allocation:
N/A (single arm study)
Control:
  • Uncontrolled/single arm
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Single (group)
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Uniklinik RWTH Aachen

Recruitment period and number of participants

Planned study start date:
2023-03-15
Actual study start date:
2023-03-15
Planned study completion date:
2023-06-14
Actual Study Completion Date:
No Entry
Target Sample Size:
2223
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
no minimum age
Maximum Age:
no maximum age
Additional Inclusion Criteria:
All patients and anesthesiologists who are in a running operating theatre at 09.00 o'clock at the day of the cross-sectional assessment

Exclusion Criteria

none

Addresses

Primary Sponsor

Uniklinik RWTH Aachen
Pauwelsstraße 30
52074 Aachen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik für Anästhesiologie, Uniklinik RWTH Aachen
Dr. med. Linda Grüßer
Pauwelsstraße 30
52074 Aachen
Germany
Telephone:
+ 49 241 80 88179
Fax:
+49 241 80 82406
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Klinik für Anästhesiologie, Uniklinik RWTH Aachen
Dr. med. Linda Grüßer
Pauwelsstraße 30
52074 Aachen
Germany
Telephone:
+ 49 241 80 88179
Fax:
+49 241 80 82406
Contact per E-Mail
URL:
No Entry

Principal Investigator

Klinik für Anästhesiologie, Uniklinik RWTH Aachen
Dr. med. Linda Grüßer
Pauwelsstraße 30
52074 Aachen
Germany
Telephone:
+ 49 241 80 88179
Fax:
+49 241 80 82406
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)

Dräger-Stiftung
Moislinger Allee 53−55
23558 Lübeck
Germany
Telephone:
+49 451 882 2151
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Private sponsorship (foundations, study societies, etc.)

Deutsche Gesellschaft für Anästhesiologie und Intensivmedizin
Neuwieder Straße 9
90411 Nürnberg
Germany
Telephone:
+49 911 933780
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission an der Med. Fakultät der RWTH Aachen am Universitätsklinikum Aachen
Pauwelsstr. 30
52074 Aachen
Germany
Telephone:
+49-241-8089963
Fax:
+49-241-8082012
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2022-11-09
Ethics committee number:
22-384
Vote of the Ethics Committee:
No approval required according to the EC
Date of the vote:
2022-11-28

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry