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Oxygen DeficiencyNCT05480748

Oxygen Reserve Index Predicting Hypoxemia

An observational study of Oxygen Deficiency and Apnea, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

After obtaining the approval of the hospital ethics committee, this prospective, observational study included written informed consent from 51 participants with 19<BMI<25 m/kg2 and 51 participants with BMI>40 m/kg2 undergoing an elective surgical requiring endotracheal intubation. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Oxygen Deficiency, Apnea
What is being tested?
monitoring
Type of treatment
Medical device
How many people
51 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2022to 23 Jun 2022
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 102 patients, ASA 1-3, 18-75 years

Who may be able to join

  • 18-75 years,
  • ASA 1-3,
  • BMI>40 kg/m2 (morbidly obesity)
  • 19<BMI<25 kg/m2 ,
  • Elective surgical procedure requiring general anesthesia with endotracheal intubation

Who cannot join

  • History of cardiopulmonary disease,
  • 25<BMI<40 kg m2,
  • <18 years of age,
  • Difficult intubation,
  • Pregnancy,
  • Hemoglobinopathies
  • Preoperative hemoglobin of less than 10.0 mg/dL

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • University of Health Science, Kartal Dr Lütfi Kırdar Training and Research Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Oxygen Reserve Index in Predicting Hypoxemia in Morbidly Obese Patients

After obtaining the approval of the hospital ethics committee, this prospective, observational study included written informed consent from 51 participants with 19<BMI<25 m/kg2 and 51 participants with BMI>40 m/kg2 undergoing an elective surgical requiring endotracheal intubation. In addition to standard monitors, an oxygen reserve index (ORI) sensor was placed and baseline values were recorded. The participants were preoxygenated until end expiratory oxygen concentration (EtO2) is reached 90%. After anesthesia induction and endotracheal intubation, the breathing circuit was not connected endotracheal tube until the peripheral oxygen saturation (SpO2) decreased until 95%.ORİ and SpO2 values were continuously recorded. Time of tolerable apnea, ORI warning, SpO2 warning and added warning were also recorded.

Read the detailed description

This single-center prospective, observational study was approved by Institutional Ethics Committee (Decision No:2022/514/222/9, Date:30/03/2022) and was performed in accordance with the Declaration of Helsinki. Written, informed consent was obtained from 51 participants with BMI>40 kg/m2(morbidly obesity) and 51 participants with19<BMI<25 kg/m2(normal BMI), 18-75 aged, American Society of Anesthesiologists (ASA) physical status I-III scheduled for an elective surgical procedure requiring general anesthesia with endotracheal intubation. Participants with significant history of cardiopulmonary disease, 25<BMI<40 kg m2, ASA>4 and<18 years of age, difficult intubation, pregnancy, hemoglobinopathies and preoperative hemoglobin of less than 10.0 mg/dL were defined as exclusion criteria.

Standard monitors were routinely established for each participants, including heart rate (HR), noninvasive blood pressure measurements. In addition, an ORi and SpO2 were measured simultaneously at 1-s interval with a pulse oximetry sensor (Rainbow sensor, R2-25) applied to the finger and connected to a Masimo Root with Radical-7 pulse oximeter (Masimo Corp.) Data for analysis was downloaded from the Root monitor.

Following the placement of monitors, baseline values were recorded. Participants were then preoxygenated with spontaneous ventilation and 100% inspirative oxygen concentrate (FiO2) at a flow rate of 8 liter/minute via a tight-fitting face mask until EtO2 is reached to 90%. Anesthesia was induced with intravenous midazolam, fentanyl, propofol and rocuronium in 100% FiO2.The trachea was intubated after 3-4 minutes under direct visualization using a videolaryngoscope to confirm placement.The endotracheal tube was not connected to the breathing circuit, and the participants remained apneic. The World Health Organization defines intraoperative SpO2 ≥ 95% as normal in its training materials, and treatment steps are mentioned for SpO2 ≤ 94% [12]. However, since we included morbidly obese participants with limited functional residual capacities in our study and wanted to stay with in the safe range, we allowed SpO2 to decrease up to 95%. At the same time, the alarm point for SpO2 is applied as 95% in our clinic's protocol for morbidly obese patients.

ORi and SpO2 values were recorded continuously. Subsequently, the anesthesia circuit was connected and patients were ventilated with 100% Fraction of Inspired Oxygen ( FiO2), tidal volume targeted 7 ml/kg and 5 cmH2O of positive end-expiratory pressure until ORi plateaued.Thereafter, anesthesia continued per routine.

ORi and SpO2 data were compared at five specific time points: 1) baseline; 2) at the end of pre-oxygenation when the EtO2 reaches to 90%; 3) at the beginning of intubation; 4) when SpO2 reaches 95%; and 6) during ventilation with 100% FiO2 when the ORi reaches a plateau.

Investigators also recorded the tolerable apnea time defined as the time from the beginning of apnea until SpO2 reached 95% and ventilation was reinstated. The ORi warning time was defined as the time between the onset of the ORi and the SpO2 reaching 95%. Investigators defined the SpO2 warning time as the time for SpO2 to decrease from 97% to 95%.The added warning time provided by ORi was defined as the difference between ORi warning time and SpO2 warning time The time at which the ORi alarm. Alarm activation was based on the fractional rate of change in ORi rather than on a specific oxygen reserve value.

Being tested
monitoring
Keywords
Oxygen reserve index,, Tolerable apnea time,, Oxygen reserve index warning time,, Preoxygenation,, Percutaneous oxygen saturation warning time
Medical subject headings
Hypoxia, Apnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • monitoringDevice

    ORI warning time, SpO2 warning time, added time were recorded.

Study groups in NCT05480748
Study groupRoleWhat they receive
Group 1: 19>BMI<25 AND BMI>4051 patients with BMI>40 kg/m2 (morbidly obesity) and 51 patients with 19<BMI<25 kg/m2 (normal BMI), 18-75 aged, American Society of Anesthesiologists (ASA) physical status I-III scheduled for an elective surgical procedure requiring general anesthesia with endotracheal intubation.
Receives: Device: monitoring
Normal body mass index and morbidly obese groups51 patients with BMI>40 kg/m2 (morbidly obesity) and 51 patients with 19<BMI<25 kg/m2 (normal BMI), 18-75 aged, American Society of Anesthesiologists (ASA) physical status I-III scheduled for an elective surgical procedure requiring general anesthesia with endotracheal intubation.
Receives: Device: monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In morbidly obese patients oxygen reserve index (ORi) warning time, SpO2 warning time, and added warning time defined as the difference between the two to set deadlines in specific time periods.

    Primary endpoint; To evaluate whether ORi provides an earlier, more relevant clinical warning of impending desaturation compared to pulse oximetry in morbidly obese patients.

    Measured: 'Time until ORI reaches to 0.24 (It is evaluated in the first 15 minutes after the patient is given anesthesia)

Secondary outcomes (2)
  1. In morbidly obese patients oxygen reserve index (ORi) warning time, SpO2 warning time, and added warning time defined as the difference between the two to set deadlines in specific time periods.

    secondary endpoint was; to compare the added warning time in patients with normal body mass index (BMI) and morbid obesity.

    Measured: Time until SpO2 drops to 95% after ORi reaches 0.24 (until 30 minutes)

  2. In morbidly obese patients oxygen reserve index (ORi) warning time, SpO2 warning time, and added warning time defined as the difference between the two to set deadlines in specific time periods.

    secondary endpoint was; to compare the tolerable apne time in patients with normal body mass index (BMI) and morbid obesity.

    Measured: Time from intubation until SpO2 drops to 95% (until 30 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2022
  2. Study start1 Apr 2022
  3. Primary completion30 May 2022
  4. Study completion23 Jun 2022

Resources

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
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05480748
Sponsor's protocol ID
DrLutfiKirdarANEST
Status last verified
May 2024
First submitted
23 Jun 2022
Last updated
14 May 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: I will share the parameters and results of the study.

Publications

  • Fleming NW, Singh A, Lee L, Applegate RL 2nd. Oxygen Reserve Index: Utility as an Early Warning for Desaturation in High-Risk Surgical Patients. Anesth Analg. 2021 Mar 1;132(3):770-776. doi: 10.1213/ANE.0000000000005109.

    PubMed 32815872
  • Tsymbal E, Ayala S, Singh A, Applegate RL 2nd, Fleming NW. Study of early warning for desaturation provided by Oxygen Reserve Index in obese patients. J Clin Monit Comput. 2021 Aug;35(4):749-756. doi: 10.1007/s10877-020-00531-w. Epub 2020 May 18.

    PubMed 32424516
  • Saracoglu KT, Arslan G, Saracoglu A, Sezen O, Ratajczyk P, Gaszynski T. Oxygen reserve index vs. peripheral oxygen saturation for the prediction of hypoxemia in morbidly obese patients: a prospective observational study. BMC Anesthesiol. 2024 Oct 11;24(1):367. doi: 10.1186/s12871-024-02755-8.

    PubMed 39394112

Questions about this trial

What is this clinical trial studying?

An observational study of Oxygen Deficiency and Apnea, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital 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 7 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 14 May 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?

In morbidly obese patients oxygen reserve index (ORi) warning time, SpO2 warning time, and added warning time defined as the difference between the two to set deadlines in specific time periods. (time frame: 'Time until ORI reaches to 0.24 (It is evaluated in the first 15 minutes after the patient is given anesthesia)). 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 NCT05480748, which also lists 3 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 14 May 2024.

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