Pre-operative ExerciseNCT06401096
Evaluation of the Effects of Preoperative Breathing Exercises on Preoxygenation Period
An observational study of Pre-operative Exercise, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-operative Exercise
- What is being tested?
- Preoperative respiratory exercises
- Type of treatment
- Surgery or procedure
- How many people
- 194 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 16 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Çankaya, 06530
About this study
Official title: 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.
Read the 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.
- Conditions
- Pre-operative Exercise
- Being tested
- Preoperative respiratory exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative respiratory exercisesProcedure or surgery
Also called Incentive spirometer
The Triflo Exerciser
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Preoperative respiratory exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration (sec) for end-tidal oxygen level to rise to 85%
The investigators aimed to compare the duration for end-tidal oxygen level to rise 85% of two groups (C and T)
Measured: Between 0th minute and 5th minute of preoxygenation period
Duration (sec) for oxygen reserve index to rise to 0.55
The investigators aimed to compare the duration for oxygen reserve index to rise to 0.55 of two groups (C and T)
Measured: Between 0th minute and 5th minute of preoxygenation period
Secondary outcomes (13)
Duration (sec) for end-tidal oxygen level to rise to 85% according to patient's age
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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.
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.
Measured: 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.
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.
Measured: 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
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
Measured: 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
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
Measured: 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
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.
Measured: 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
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.
Measured: Between 0th minute and 5th minute of preoxygenation period
Oxygen saturation level (%) at the beginning and end of 5-day 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).
Measured: In the preoperative period before the initiation of triflo exercise and before preoxygenation after 5 days of triflo exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 May 2024
- Primary completion1 Sep 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pre-operative ExerciseStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, furkan güneş, Ankara City Hospital Bilkent
- Investigators
- Nermin Gögüş, Principal investigator, Ankara Bilkent City Hospital, Anesthesiology and Reanimation Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401096
- Sponsor's protocol ID
- E1-23-4220
- Status last verified
- Oct 2024
- First submitted
- 2 May 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29367198Hulzebos 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.
PubMed 17047215Kundra 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.
PubMed 20551816Chen 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.
PubMed 31904726Scheeren 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.
PubMed 28791567
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Preoperative Breathing Exercises on ORI (Oxygen Reserve Index) and ETO2 in Patients Undergoing Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06401096
- Acronym / sponsor ID
- E1-23-4220
- Conditions
- Pre-operative Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) | – | Procedure: Preoperative respiratory exercisesThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative respiratory exercisesAlso: Incentive spirometerThe Triflo Exerciser | Procedure or surgery | Triflo (T) |
Primary outcome
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)
13 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Background: PubMed 29367198Boden 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.
- Background: PubMed 17047215Hulzebos 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.
- Background: PubMed 20551816Kundra 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.
- Background: PubMed 31904726Chen 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.
- Background: PubMed 28791567Scheeren 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nermin Gögüş principal investigator
Ankara Bilkent City Hospital, Anesthesiology and Reanimation Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-operative Exercise, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration (sec) for end-tidal oxygen level to rise to 85% (time frame: Between 0th minute and 5th minute of preoxygenation period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06401096, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.