NCT04352049

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2014

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

2.5 years

First QC Date

April 10, 2020

Last Update Submit

April 15, 2020

Conditions

Anesthesia; Functional

Keywords

airway managementgeneral anaesthesiastandard of carerespirationneurophysiological monitoring.

Outcome Measures

Primary Outcomes (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.

    Preoxygenation period, an average of 10 minutes

Secondary Outcomes (5)

  • pO2

    Preoxygenation period, an average of 10 minutes

  • pCO2

    Preoxygenation period, an average of 10 minutes

  • bispectral index (BIS)

    Preoxygenation period, an average of 10 minutes

  • Cardiac index (CI)

    Preoxygenation period, an average of 10 minutes

  • continuous intra-arterial blood pressure

    Preoxygenation period, an average of 10 minutes

Study Arms (2)

3TV group

ACTIVE COMPARATOR

Patients 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

Procedure: Preoxygenation

8DB group

ACTIVE COMPARATOR

Or eight vital capacity breaths for 1 minute with FGF of 10 L/min

Procedure: Preoxygenation

Interventions

PreoxygenationPROCEDURE
3TV group8DB group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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,
  • cerebral vascular disorders,
  • hemoglobin less than 13g.dL-1,
  • low-quality rScO2 signal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Manuel Gómez-Ríos

A Coruña, Galicia, 15006, Spain

Location

Complexo Hospitalario Universitario de A Coruña

A Coruña, 15004, Spain

Location

Related Publications (4)

  • 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.

    PMID: 31584884BACKGROUND

  • 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.

    PMID: 30770057BACKGROUND

  • 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.

    PMID: 26556848BACKGROUND

  • 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.

    PMID: 21182603BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jose C Garzón, MD

    Complejo Asistencial Salamanca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

April 10, 2020

First Posted

April 17, 2020

Study Start

April 15, 2012

Primary Completion

October 15, 2014

Study Completion

October 15, 2014

Last Updated

April 17, 2020

Record last verified: 2020-04

Locations

ES(2)