Skip to main content
OpenTrials
Completed

NCT Number: NCT06401096

Evaluation of the Effects of Preoperative Breathing Exercises on Preoxygenation Period

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, Çankaya, 06530, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Preoperative respiratory exercises

Procedure

The Triflo Exerciser

Other names: Incentive spirometer

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. 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).

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 6, 2024
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.