Evaluation of the Effects of Preoperative Breathing Exercises on Preoxygenation Period

October 15, 2024 updated by: furkan güneş, Ankara City Hospital Bilkent

Evaluation of the Effects of Preoperative Breathing Exercises on ORI (Oxygen Reserve Index) and ETO2 in Patients Undergoing Abdominal Surgery

The aim of this observational study is to compare the effects of preoperative breathing exercises during the preoxygenation period in patients undergoing abdominal surgery.

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.

Detailed Description

Patients who are planned for abdominal surgery under elective conditions and who meet the inclusion criteria will be divided into 2 groups after routine preoperative preparations. The 1st group will start at least 5 days before the preoperative period and until the preoperative period, a minimum of 5 minutes of effective triflo exercise will be performed 4 times a day under the supervision of a nurse, and the 2nd group (control group) will not be exercised except for routine preoperative preparation. Age, existing chronic diseases, body mass index, haemoglobin levels, smoking status, presence or absence of lung disease, SpO2 values before and at the end of respiratory exercise (in the preoperative respiratory exercise group) will be recorded. All patients will be monitored with ECG, SpO2, non invasive blood pressure, Masimo. After the patients are taken to the operating table, they will be preoxygenated with oxygen at FiO2 100% at 10 L\min in supine position, with the anaesthesia mask placed on the patient's face so that there is no leakage. Patients will be preoxygenated until ETO2 concentration reaches 85%. When preoxygenation is started, the timer will be started and the time to reach ORI:0.55 and the time to reach ETO2 85% will be measured and recorded with a timer. Preoxygenation time will be limited to a maximum of 5 minutes and patients who do not reach ETO2 concentration 85% or ORI:0.55 within 5 minutes will be noted.

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.
Observational

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.
194

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
    • Çankaya
      • Ankara, Çankaya, Turkey, 06530
        • Ankara Bilkent City Hospital

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who will undergo elective abdominal surgery under general anesthesia in Ankara Bilkent City Hospital Operating Room, between the ages of 18-65, both genders and ASA I-III risk group who agree to participate in the study will be included.

Description

Inclusion Criteria:

  • Patients who will undergo elective abdominal surgery under general anesthesia
  • Between the ages of 18-65
  • Both genders
  • ASA I-III risk group
  • Patients who accept and give consent to participate in the study

Exclusion Criteria:

  • Patients who did not agree to participate in the study
  • Patients younger than 18 years old and older than 65 years old
  • Patients with advanced heart failure
  • Conditions where the patient is uncooperative (e.g. dementia, Alzheimer's)
  • Patients who refuse to breathe through the mask before EtO2 reaches 85% or more after the preoxygenation process begins
  • Patients who cannot reach the EtO2 level of 85% within five minutes
  • Deeply Anemic Patients (Hb<8 gr/dl)
  • Patients with neurological sequelae
  • Patients with conditions that may prevent effective preoxygenation (those with long beards, patients with a nasogastric tube, etc.)

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Control (C)
Patients in the control group who will undergo abdominal surgery will not be given any breathing exercises other than routine preoperative preparation. After appropriate anesthesia preparation, preoxygenation will begin.
Triflo (T)
The patient group who receives breathing exercises will be given effective triflo exercise under the supervision of a nurse, starting with hospitalization at least 5 days before the operation and until the pre-operative period. Triflo working time will be planned to be minimum 5 minutes 4 times a day. Breathing exercise will be performed with both inhalation and exhalation. After appropriate anesthesia preparation, preoxygenation will begin.
Procedure: Preoperative respiratory exercises
The Triflo Exerciser
Other Names:
  • Incentive spirometer

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
Duration (sec) for end-tidal oxygen level to rise to 85%
Time Frame: Between 0th minute and 5th minute of preoxygenation period
The investigators aimed to compare the duration for end-tidal oxygen level to rise 85% of two groups (C and T)
Between 0th minute and 5th minute of preoxygenation period
Duration (sec) for oxygen reserve index to rise to 0.55
Time Frame: Between 0th minute and 5th minute of preoxygenation period
The investigators aimed to compare the duration for oxygen reserve index to rise to 0.55 of two groups (C and T)
Between 0th minute and 5th minute of preoxygenation period

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
Duration (sec) for end-tidal oxygen level to rise to 85% according to patient's age
Time Frame: Between 0th minute and 5th minute of preoxygenation period
The investigators aimed to compare the duration for end-tidal oxygen level to rise 85% of two groups (C and T) according to patient's age
Between 0th minute and 5th minute of preoxygenation period
Duration (sec) for oxygen reserve index to rise to 0.55 according to patient's age
Time Frame: Between 0th minute and 5th minute of preoxygenation period
The investigators aimed to compare the duration for oxygen reserve index to rise to 0.55 of two groups (C and T) according to patient's age
Between 0th minute and 5th minute of preoxygenation period
Duration (sec) for end-tidal oxygen level to rise to 85% according to patient's BMI
Time Frame: Between 0th minute and 5th minute of preoxygenation period
The investigators aimed to compare the duration for end-tidal oxygen level to rise 85% of two groups (C and T) according to patient's BMI
Between 0th minute and 5th minute of preoxygenation period
Duration (sec) for oxygen reserve index to rise to 0.55 according to patient's BMI
Time Frame: Between 0th minute and 5th minute of preoxygenation period
The investigators aimed to compare the duration for oxygen reserve index to rise to 0.55 of two groups (C and T) according to patient's BMI
Between 0th minute and 5th minute of preoxygenation period
Duration (sec) for end-tidal oxygen level to rise to 85% according to patient's gender
Time Frame: Between 0th minute and 5th minute of preoxygenation period
The investigators aimed to compare the duration for end-tidal oxygen level to rise 85% of two groups (C and T) according to patient's gender
Between 0th minute and 5th minute of preoxygenation period
Duration (sec) for oxygen reserve index to rise to 0.55 according to patient's gender
Time Frame: Between 0th minute and 5th minute of preoxygenation period
The investigators aimed to compare the duration for oxygen reserve index to rise to 0.55 of two groups (C and T) according to patient's gender
Between 0th minute and 5th minute of preoxygenation period
Duration (sec) for end-tidal oxygen level to rise to 85% depending on whether the patients had known lung disease or not.
Time Frame: Between 0th minute and 5th minute of preoxygenation period
The investigators aimed to compare the duration for end-tidal oxygen level to rise 85% of two groups (C and T) depending on whether the patients had known lung disease or not.
Between 0th minute and 5th minute of preoxygenation period
Duration (sec) for oxygen reserve index to rise to 0.55 depending on whether the patients had known lung disease or not.
Time Frame: Between 0th minute and 5th minute of preoxygenation period
The investigators aimed to compare the duration for oxygen reserve index to rise to 0.55 of two groups (C and T) depending on whether the patients had known lung disease or not.
Between 0th minute and 5th minute of preoxygenation period
Duration (sec) for end-tidal oxygen level to rise to 85% according to patient's hemoglobin level
Time Frame: Between 0th minute and 5th minute of preoxygenation period
The investigators aimed to compare the duration for end-tidal oxygen level to rise 85% of two groups (C and T) according to patient's hemoglobin level
Between 0th minute and 5th minute of preoxygenation period
Duration (sec) for oxygen reserve index to rise to 0.55 according to patient's hemoglobin level
Time Frame: Between 0th minute and 5th minute of preoxygenation period
The investigators aimed to compare the duration for oxygen reserve index to rise to 0.55 of two groups (C and T) according to patient's hemoglobin level
Between 0th minute and 5th minute of preoxygenation period
Duration (sec) for the end-tidal oxygen level to rise to 85% according to whether the patient smokes or not
Time Frame: Between 0th minute and 5th minute of preoxygenation period
The investigators aimed to compare the duration for end-tidal oxygen level to rise 85% of two groups (C and T) according to whether the patient smoked or not.
Between 0th minute and 5th minute of preoxygenation period
Duration (sec) for the oxygen reserve index to rise to 0.55 according to whether the patient smokes or not
Time Frame: Between 0th minute and 5th minute of preoxygenation period
The investigators aimed to compare the duration for oxygen reserve index to rise to 0.55 of two groups (C and T) according to whether the patient smoked or not.
Between 0th minute and 5th minute of preoxygenation period
Oxygen saturation level (%) at the beginning and end of 5-day triflo exercise
Time Frame: In the preoperative period before the initiation of triflo exercise and before preoxygenation after 5 days of triflo exercise
The investigators aimed to examine whether there was a significant difference between oxygen saturations before the start of the study and at the end of the 5-day study in the group of patients who underwent Triflo exercise (T).
In the preoperative period before the initiation of triflo exercise and before preoxygenation after 5 days of triflo exercise

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.
Ankara City Hospital Bilkent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nermin Gögüş, ankara bilkent city hospital, anesthesiology and reanimation clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
May 1, 2024

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.
September 1, 2024

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.
October 16, 2024

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).
May 2, 2024

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.
May 2, 2024

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.
May 6, 2024

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.
October 17, 2024

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.
October 15, 2024

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.
October 1, 2024

More Information

Terms related to this study

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.
  • E1-23-4220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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