Is Low Flow Anaesthesia Feasible?

Anesthesia Clinical Trial

Official title:

Low Flow Anaesthesia is Good But Feasible?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06389669
• Other study ID #: Inonu LTI
• Status: Not yet recruiting
• Start date: May 15, 2024
• Est. completion date: September 15, 2024

Study information

• Verified date: May 2024
• Source: Inonu University
• Contact: Yusuf Z Colak, Assoc.Prof.
• Phone: +90(422)3410660
• Email: yusuf.colak[@]inonu.edu.tr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: September 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia

Locations

Country	Name	City	State
Turkey	Inonu Univercity	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Factors affecting oxygen consumption	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