Is Low Flow Anaesthesia Feasible?

May 8, 2024 updated by: Yusuf Ziya ÇOLAK, Inonu University

Low Flow Anaesthesia is Good But Feasible?

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Inhaler anaesthesia will be administered after anaesthesia induction and tracheal intubation. Fresh gas flow (FGF) will be determined as 1 l/min, MAC=1, FiO2=40% with target controlled automatic gas control mode (AGC). FGF will be decreased to 0.5 l/min 10 minutes after surgical incision, if successful, it will be decreased to 0.3 l/min 10 minutes later and it will be checked whether it is successful. The study will be terminated and FGF will be increased to 1 l/min again.

Demographic data of the patients and FGF levels that can provide FiO2=40% will be recorded.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Malatya, Turkey, 44280
        • Inonu Univercity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • Patients undergoing surgery under general anaesthesia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Low Flow Anaesthesia
Time Frame: The measurement will start 10 minutes after the surgical incision and end 20 minutes later
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors affecting oxygen consumption
Time Frame: The measurement will start 10 minutes after the surgical incision and end 20 minutes later
To find out which of the patient's physical characteristics that affect oxygen consumption may be determinant.
The measurement will start 10 minutes after the surgical incision and end 20 minutes later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Investigators

  • Principal Investigator: Yusuf Z Colak, Assoc.Prof., Inonu University Anaesthesiology and Reanimation Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2024

Primary Completion (Estimated)

August 15, 2024

Study Completion (Estimated)

September 15, 2024

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Inonu LTI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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