Evaluation of the Effects of Preoperative Breathing Exercises on Preoxygenation Period

NCT ID: NCT06401096

Last Updated: 2024-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

194 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-10-16

Brief Summary

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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

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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

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Pre-operative Exercise

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

Preoperative respiratory exercises

Intervention Type PROCEDURE

The Triflo Exerciser

Interventions

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Preoperative respiratory exercises

The Triflo Exerciser

Intervention Type PROCEDURE

Other Intervention Names

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Incentive spirometer

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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furkan güneş

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nermin Gögüş

Role: PRINCIPAL_INVESTIGATOR

Ankara Bilkent City Hospital, Anesthesiology and Reanimation Clinic

Locations

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Ankara Bilkent City Hospital

Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 29367198 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17047215 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20551816 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31904726 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28791567 (View on PubMed)

Other Identifiers

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E1-23-4220

Identifier Type: -

Identifier Source: org_study_id

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