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Clinical Trials/NCT06401096
NCT06401096
Completed
Not Applicable

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

Ankara City Hospital Bilkent1 site in 1 country194 target enrollmentMay 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pre-operative Exercise
Sponsor
Ankara City Hospital Bilkent
Enrollment
194
Locations
1
Primary Endpoint
Duration (sec) for end-tidal oxygen level to rise to 85%
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
October 16, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

furkan güneş

Principal Investigator

Ankara City Hospital Bilkent

Eligibility Criteria

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.)

Outcomes

Primary Outcomes

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)

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

  • Duration (sec) for end-tidal oxygen level to rise to 85% according to patient's age(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(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(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(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(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(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(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.(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(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(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.(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(Between 0th minute and 5th minute of preoxygenation period)
  • Oxygen saturation level (%) at the beginning and end of 5-day triflo exercise(In the preoperative period before the initiation of triflo exercise and before preoxygenation after 5 days of triflo exercise)

Study Sites (1)

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