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Anesthesia; FunctionalNCT04352049

Assessment Through Transcutaneous Brain Oximetry (NIRS) of Two Preoxygenation Techniques

A study testing Preoxygenation in people with Anesthesia; Functional, run by Complexo Hospitalario Universitario de A Coruña at 2 sites in Spain.

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

Preoxygenation techniques is currently considered a standard of care, but how they influence cerebral oxygenation remains largely unknown. In this study, the investigators compare three minutes tidal volume breathing versus eight vital capacity, deep breaths (8DB) technique. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Anesthesia; Functional
What is being tested?
Preoxygenation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
2 sitesSpain
Study dates
15 Apr 2012to 15 Oct 2014
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Healthy adult patients scheduled for surgery under general anaesthesia with tracheal intubation
  • ASA physical status 1
  • aged between 18 and 65 years.

Who cannot join

  • Baseline peripheral oxygen saturation (SpO2) of less than 95%,
  • BMI > 30 kg.m-2,
  • cardiac, respiratory or brain diseases,
  • previous or active smoking,
  • predicted difficult airway,
  • frontal sinusitis,
Show all 9Show fewer
  • cerebral vascular disorders,
  • hemoglobin less than 13g.dL-1,
  • low-quality rScO2 signal.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Manuel Gómez-Ríos

    A Coruña, Galicia, 15006

  • Complexo Hospitalario Universitario de A Coruña

    A Coruña, 15004

Other trials in Spain

About this study

Official title: Comparing the Dynamics of Changes in Regional Cerebral Oxygen Saturation With Arterial Oxygen Partial Pressure With Two Techniques of Preoxygenation in Healthy Adults

Preoxygenation techniques is currently considered a standard of care, but how they influence cerebral oxygenation remains largely unknown. In this study, the investigators compare three minutes tidal volume breathing versus eight vital capacity, deep breaths (8DB) technique. Forty-eight patients scheduled for surgery under general anesthesia were included in a randomized study design. The main endpoints were arterial partial pressure of O2 (PaO2) and regional cerebral oxygen saturation (rScO2 ; INVOS TM -5100- C) which were measured at baseline (T1), end of pre-oxygenation (T2) and after desaturation during apnoea to 95% (T3).

Read the detailed description

Hypoxemia secondary to the inability to secure the airway remains the main cause of anesthesia-related morbidity and mortality. Preoxygenation with 100% oxygen before induction of anesthesia is currently considered a standard of care and practiced routinely for all patients, and especially carefully for high-risk cases. It is an essential component of the rapid sequence induction technique.

Common pre-oxygenation techniques include the 3 min tidal volume breathing (3TV) and the eight vital capacity, deep breaths (8DB). Their efficiency has been extensively assessed by measuring the rate of decline of SaO2 during apnea after induction/paralysis, with 'time to desaturation (to 95% or 90%) being the endpoint of many studies. This is arguably a surrogate endpoint for oxygen stores and Pandit et al. estimated the total amount of oxygen taken up by the body in these techniques using breath-by-breath gas analysis. An even more relevant measure is the impact of preoxygenation on tissue stores of oxygen, but this is difficult to quantify. Especially, given its vulnerability to hypoxemia due to its high energy requirements compared to the low energy reserves, the brain is particularly susceptible.

Cerebral oximetry is a noninvasive monitoring technique that uses near-infrared spectroscopy (NIRS) to measure regional cerebral oxygen saturation (rScO2). Continuous rScO2 monitoring has shown to be useful in detecting mismatch of oxygen supply and demand in the brain and assessing cerebral autoregulation in real-time. This offers a means to measure tissue oxygenation in a relevant organ with pre-oxygenation.

The primary aim of the present study was to test the hypothesis that different pre-oxygenation techniques result in different degrees of cerebral oxygenation as measured by rScO2 with the INVOSTM-5100-C. The investigators wished to compare the 3TV method with the 8DB method, as being the two methods that produced the highest increases in body oxygen stores in previous experiments; the null hypothesis that these would yield similar degrees of brain oxygenation. The investigators also wished to assess whether, regardless of the preoxygenation technique, there were differences between arterial PO2 and rScO2 dynamics with preoxygenation and subsequent apnoea.

Being tested
Preoxygenation
Keywords
airway management, general anaesthesia, standard of care, respiration, neurophysiological monitoring.
Medical subject headings
Respiratory Aspiration

What participants receive

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

  • PreoxygenationProcedure or surgery

Study groups in NCT04352049
Study groupRoleWhat they receive
3TV groupActive comparatorPatients were randomly assigned to receive either three minutes tidal volume (3TV) with a fresh gas flow (FGF 100% O2) via facemask of 5 L/min
Receives: Procedure: Preoxygenation
8DB groupActive comparatorOr eight vital capacity breaths for 1 minute with FGF of 10 L/min
Receives: Procedure: Preoxygenation

What is being measured

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

  1. Cerebral regional oxygen saturation (rScO2)

    rScO2 using an INVOSTM 5100C monitor (Somanetics Corporation, Michigan, USA) and Adult SomaSensor® SAFB-SM sensors (Covidien LLC, MA, USA) placed according to the manufacturers' instructions.

    Measured: Preoxygenation period, an average of 10 minutes

Secondary outcomes (5)

  1. pO2

    partial pressure of oxygen through samples for arterial blood gas analyses using the GEM® Premier 3000 monitor (Instrumentation Laboratory. Lexington, MA, USA).

    Measured: Preoxygenation period, an average of 10 minutes

  2. pCO2

    partial pressure of CO2 through samples for arterial blood gas analyses using the GEM® Premier 3000 monitor (Instrumentation Laboratory. Lexington, MA, USA).

    Measured: Preoxygenation period, an average of 10 minutes

  3. bispectral index (BIS)

    by means of a BIS VISTATM monitor (Aspect Medical Systems Inc, Massachusetts, USA)

    Measured: Preoxygenation period, an average of 10 minutes

  4. Cardiac index (CI)

    using a VigileoTM monitor (Edwards Lifesciences LLC. Irvine, USA

    Measured: Preoxygenation period, an average of 10 minutes

  5. continuous intra-arterial blood pressure

    . A 20-G cannula was placed in the left radial artery to obtain continuous intra-arterial blood pressure

    Measured: Preoxygenation period, an average of 10 minutes

Timeline

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

  1. First posted17 Apr 2020
  2. Study start15 Apr 2012
  3. Primary completion15 Oct 2014
  4. Study completion15 Oct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04352049
Sponsor's protocol ID
JCG-PTO-2012
Status last verified
Apr 2020
First submitted
10 Apr 2020
Last updated
17 Apr 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Joffe AM, Aziz MF, Posner KL, Duggan LV, Mincer SL, Domino KB. Management of Difficult Tracheal Intubation: A Closed Claims Analysis. Anesthesiology. 2019 Oct;131(4):818-829. doi: 10.1097/ALN.0000000000002815.

    PubMed 31584884

  • Baillard C, Boubaya M, Statescu E, Collet M, Solis A, Guezennec J, Levy V, Langeron O. Incidence and risk factors of hypoxaemia after preoxygenation at induction of anaesthesia. Br J Anaesth. 2019 Mar;122(3):388-394. doi: 10.1016/j.bja.2018.11.022. Epub 2018 Dec 29.

    PubMed 30770057

  • Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.

    PubMed 26556848

  • Pandit JJ. The analysis of variance in anaesthetic research: statistics, biography and history. Anaesthesia. 2010 Dec;65(12):1212-20. doi: 10.1111/j.1365-2044.2010.06542.x.

    PubMed 21182603

Questions about this trial

What is this clinical trial studying?

A study testing Preoxygenation in people with Anesthesia; Functional, run by Complexo Hospitalario Universitario de A Coruña at 2 sites in Spain.

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 3 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 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. 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?

Cerebral regional oxygen saturation (rScO2) (time frame: Preoxygenation period, an average of 10 minutes). 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 NCT04352049, which also lists 4 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 Apr 2020.

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