Assessing Lung Dynamics and Respiratory Functions in Minimal Flow Anesthesia: A Prospective Study

September 20, 2023 updated by: Erkan Cem ÇELİK, Ataturk University

EVALUATION OF LUNG DYNAMICS AND RESPIRATORY FUNCTIONS IN PATIENTS APPLIED WITH MINIMAL FLOW ANESTHESIA: A PROSPECTIVE, RANDOMIZED STUDY

The patients were randomized into two groups medium flow anesthesia (MeFA) and minimal flow anesthesia (MiFA). While MeFA received medium flow anesthesia with 2 lt/min, MiFA received minimal flow anesthesia with 0.5 lt/min fresh gas flow. In both groups dynamic compliance values, peak inspiratory pressure (PIP) values, total inhalation anesthetic drug consumption, total remifentanil drug consumption, duration of anesthesia, and duration of surgery were recorded. The FVC, FEV1, and FEV1/FVC values of the patients in both groups were evaluated and noted 24 hours before the operation, after the operation 2nd, 8th, and 24th hours.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • Turkey
      • Erzurum, Turkey, 25080
        • Erkan Cem ÇELİK

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA I-II
  • 18-65 years of age, who will undergo elective laparoscopic cholecystectomy surgery

Exclusion Criteria:

  • ASA III-IV
  • Smokers
  • Body mass index (BMI) > 40 kg / m2,
  • Patients with cardiovascular system disease
  • Chronic respiratory diseases,
  • Patients whose pulmonary function tests cannot be applied and who have problems with pulmonary function tests during the examination of the chest disease consultant

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

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Medium flow anesthesia
After reaching the MAC 1 value with 4lt/min 50% O2 - 50% air and 8% desflurane medium flow anesthesia was started with 2 lt/min 50% O2 - 50% air with MAC 1 concentration desflurane.
Other: Medium flow anesthesia
Group MeFA; after reaching the MAC 1 value with 4lt/min 50% O2 - 50% air and 8% desflurane with remifentanil infusion, medium flow anesthesia was started with 2 lt/min 50% O2 - 50% air with MAC 1 concentration desflurane. The vaporizer was closed at the end of the last suture, and the flow was increased to 80% oxygen at 6 lt/min.
Experimental: Minimal flow anesthesia
After reaching the MAC 1 value with 4 lt/min 50% O2 - 50% air and 8% desflurane minimal flow anesthesia was started with 0.50 lt/min 50% O2 - 50% air with MAC 1 concentration of desflurane.
Other: Minimal flow anesthesia
Group MiFA; after reaching the MAC 1 value with 4 lt/min 50% O2 - 50% air and 8% desflurane with remifentanil infusion, minimal flow anesthesia was started with 0.50 lt/min 50% O2 - 50% air with MAC 1 concentration of desflurane. The vaporizer was closed at the end of the last suture, and the flow was increased to 80% oxygen at 6 lt/min.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dynamic Compliance assessment
Time Frame: 5th minutes after endotracheal intubation
Dynamic Compliance will be assessed 5th minutes after endotracheal intubation
5th minutes after endotracheal intubation
Dynamic Compliance assessment
Time Frame: 5th minutes after surgical incision
Dynamic Compliance will be assessed 5th minutes after the surgical incision
5th minutes after surgical incision
Dynamic Compliance assessment
Time Frame: 10th minutes after surgical incision
Dynamic Compliance will be assessed 10th minutes after the surgical incision
10th minutes after surgical incision
Dynamic Compliance assessment
Time Frame: 30th minutes after surgical incision
Dynamic Compliance will be assessed 30th minutes after the surgical incision
30th minutes after surgical incision
Dynamic Compliance assessment
Time Frame: 60th minutes after surgical incision
Dynamic Compliance will be assessed 60th minutes after the surgical incision
60th minutes after surgical incision
Dynamic Compliance assessment
Time Frame: immediately after the end of the surgical suturing
Dynamic Compliance will be assessed immediately after the end of the surgical suturing
immediately after the end of the surgical suturing
Peak inspiratory pressure assessment
Time Frame: 5th minutes after endotracheal intubation
Peak inspiratory pressure will be assessed 5th minutes after endotracheal intubation
5th minutes after endotracheal intubation
Peak inspiratory pressure assessment
Time Frame: 5th minutes after the surgical incision
Peak inspiratory pressure will be assessed 5th minutes after the surgical incision
5th minutes after the surgical incision
Peak inspiratory pressure assessment
Time Frame: 10th minutes after the surgical incision
Peak inspiratory pressure will be assessed 10th minutes after the surgical incision
10th minutes after the surgical incision
Peak inspiratory pressure assessment
Time Frame: 30th minutes after the surgical incision
Peak inspiratory pressure will be assessed 30th minutes after the surgical incision
30th minutes after the surgical incision
Peak inspiratory pressure assessment
Time Frame: 60th minutes after the surgical incision
Peak inspiratory pressure will be assessed 60th minutes after the surgical incision
60th minutes after the surgical incision
Peak inspiratory pressure assessment
Time Frame: immediately after the end of the surgical suturing
Peak inspiratory pressure will be assessed immediately after the end of the surgical suturing
immediately after the end of the surgical suturing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
FEV1 measures assessment
Time Frame: 24 hours before the operation
FEV1 measures assessment will be assessed 24 hours before the operation
24 hours before the operation
FEV1 measures assessment
Time Frame: 2nd hour after the operation
FEV1 measures assessment will be assessed 2nd hours after the operation
2nd hour after the operation
FEV1 measures assessmentt
Time Frame: 8th hour after the operation
FEV1 measures assessment will be assessed 8th hours after the operation
8th hour after the operation
FEV1 measures assessment
Time Frame: 24th hour after the operation
FEV1 measures assessment will be assessed 24th hours after the operation
24th hour after the operation
FVC measures assessment
Time Frame: 24 hours before the operation
FVC measures assessment will be assessed 24 hours before the operation
24 hours before the operation
FVC measures assessment
Time Frame: 2nd hour after the operation
FVC measures assessment will be assessed 2nd hour after the operation
2nd hour after the operation
FVC measures assessment
Time Frame: 8th hour after the operation
FVC measures assessment will be assessed 8th hour after the operation
8th hour after the operation
FVC measures assessment
Time Frame: 24th hour after the operation
FVC measures assessment will be assessed 24th hours after the operation
24th hour after the operation
FEV1/FVC measures assessment
Time Frame: 24 hours before the operation
FEV1/FVC measures assessment will be assessed 24 hours before the operation
24 hours before the operation
FEV1/FVC measures assessment
Time Frame: 2nd hour after the operation
FEV1/FVC measures assessment will be assessed 2nd hour after the operation
2nd hour after the operation
FEV1/FVC measures assessment
Time Frame: 8th hour after the operation
FEV1/FVC measures assessment will be assessed 8th hour after the operation
8th hour after the operation
FEV1/FVC measures assessment
Time Frame: 24th hour after the operation
FEV1/FVC measures assessment will be assessed 24th hour after the operation
24th hour after the operation

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ataturk University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2/106 25.03.2021

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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