NCT06389669

Brief Summary

Although low-flow anaesthesia (LFA) has been described for many years and its benefits are known, its clinical use has been limited. Concerns about the risk of hypoxia contributed to this situation. Although the risk of hypoxia is almost prevented with advanced anaesthesia machines, the use of LFA has not reached the desired levels. However, in recent years, as adverse developments related to climate change have started to affect us all, LFA has started to be on the agenda of anaesthetists again. In this study, our aim is to examine the feasibility of its clinical use in order to popularise the use of LFA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
785

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

May 23, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2024

Completed
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

April 25, 2024

Last Update Submit

October 1, 2024

Conditions

Keywords

Low Flow AnaesthesiaClosed-Circuit Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Low Flow Anaesthesia

    To determine the lowest amount of fresh gas flow, most suitable for the patient and, which can provide FiO2=40% level

    The measurement will start 10 minutes after the surgical incision and end 20 minutes later

Secondary Outcomes (1)

  • Factors affecting oxygen consumption

    The measurement will start 10 minutes after the surgical incision and end 20 minutes later

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ASA 1-2 patients who will undergo elective surgery under general anaesthesia in 38 operating rooms of Inonu University Faculty of Medicine will be prospectively recruited for 3 months (May-June-July). Emergency cases, patients under the age of 18 and over 65, laparoscopic surgeries, heart-lung surgeries that may impair oxygenation will not be included in the study.

You may qualify if:

  • Patients undergoing surgery under general anaesthesia

You may not qualify if:

  • Emergency operations
  • Previously diagnosed heart, lung, liver and kidney disease
  • Surgeries that may impair oxygenation (laparoscopic, Heart, Lung surgeries)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu Univercity

Malatya, 44280, Turkey (Türkiye)

Location

Study Officials

  • Yusuf Z Colak, Assoc.Prof.

    Inonu University Anaesthesiology and Reanimation Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD

Study Record Dates

First Submitted

April 25, 2024

First Posted

April 29, 2024

Study Start

May 23, 2024

Primary Completion

September 15, 2024

Study Completion

September 20, 2024

Last Updated

October 3, 2024

Record last verified: 2024-10

Locations