Clinical trial NCT06401096: Evaluation of the Effects of Preoperative Breathing Exercises on Preoxygenation Period
Official title: Evaluation of the Effects of Preoperative Breathing Exercises on ORI (Oxygen Reserve Index) and ETO2 in Patients Undergoing Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-operative Exercise
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.)

Primary outcomes:
measure: Duration (sec) for end-tidal oxygen level to rise to 85%
timeFrame: Between 0th minute and 5th minute of preoxygenation period
measure: Duration (sec) for oxygen reserve index to rise to 0.55
timeFrame: Between 0th minute and 5th minute of preoxygenation period
Secondary outcomes:
measure: Duration (sec) for end-tidal oxygen level to rise to 85% according to patient's age
timeFrame: Between 0th minute and 5th minute of preoxygenation period
measure: Duration (sec) for oxygen reserve index to rise to 0.55 according to patient's age
timeFrame: Between 0th minute and 5th minute of preoxygenation period
measure: Duration (sec) for end-tidal oxygen level to rise to 85% according to patient's BMI
timeFrame: Between 0th minute and 5th minute of preoxygenation period
measure: Duration (sec) for oxygen reserve index to rise to 0.55 according to patient's BMI
timeFrame: Between 0th minute and 5th minute of preoxygenation period
measure: Duration (sec) for end-tidal oxygen level to rise to 85% according to patient's gender
timeFrame: Between 0th minute and 5th minute of preoxygenation period
measure: Duration (sec) for oxygen reserve index to rise to 0.55 according to patient's gender
timeFrame: Between 0th minute and 5th minute of preoxygenation period
measure: Duration (sec) for end-tidal oxygen level to rise to 85% depending on whether the patients had known lung disease or not.
timeFrame: Between 0th minute and 5th minute of preoxygenation period
measure: Duration (sec) for oxygen reserve index to rise to 0.55 depending on whether the patients had known lung disease or not.
timeFrame: Between 0th minute and 5th minute of preoxygenation period
measure: Duration (sec) for end-tidal oxygen level to rise to 85% according to patient's hemoglobin level
timeFrame: Between 0th minute and 5th minute of preoxygenation period
measure: Duration (sec) for oxygen reserve index to rise to 0.55 according to patient's hemoglobin level
timeFrame: Between 0th minute and 5th minute of preoxygenation period
measure: Duration (sec) for the end-tidal oxygen level to rise to 85% according to whether the patient smokes or not
timeFrame: Between 0th minute and 5th minute of preoxygenation period
measure: Duration (sec) for the oxygen reserve index to rise to 0.55 according to whether the patient smokes or not
timeFrame: Between 0th minute and 5th minute of preoxygenation period
measure: Oxygen saturation level (%) at the beginning and end of 5-day triflo exercise
timeFrame: In the preoperative period before the initiation of triflo exercise and before preoxygenation after 5 days of triflo exercise
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Çankaya
Study officials:
affiliation: Ankara Bilkent City Hospital, Anesthesiology and Reanimation Clinic
name: Nermin Gögüş
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boden I, Skinner EH, Browning L, Reeve J, Anderson L, Hill C, Robertson IK, Story D, Denehy L. Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial. BMJ. 2018 Jan 24;360:j5916. doi: 10.1136/bmj.j5916.
citation: Hulzebos EH, Helders PJ, Favie NJ, De Bie RA, Brutel de la Riviere A, Van Meeteren NL. Preoperative intensive inspiratory muscle training to prevent postoperative pulmonary complications in high-risk patients undergoing CABG surgery: a randomized clinical trial. JAMA. 2006 Oct 18;296(15):1851-7. doi: 10.1001/jama.296.15.1851.
citation: Kundra P, Vitheeswaran M, Nagappa M, Sistla S. Effect of preoperative and postoperative incentive spirometry on lung functions after laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech. 2010 Jun;20(3):170-2. doi: 10.1097/SLE.0b013e3181db81ce.
citation: Chen ST, Min S. Oxygen reserve index, a new method of monitoring oxygenation status: what do we need to know? Chin Med J (Engl). 2020 Jan 20;133(2):229-234. doi: 10.1097/CM9.0000000000000625.
citation: Scheeren TWL, Belda FJ, Perel A. The oxygen reserve index (ORI): a new tool to monitor oxygen therapy. J Clin Monit Comput. 2018 Jun;32(3):379-389. doi: 10.1007/s10877-017-0049-4. Epub 2017 Aug 8.