Impact of Preoxygenation Time on End-tidal Oxygen Concentration and on Hypoxic Events Occurring After Intubation in the Intensive Care Unit.

NCT04148443 | Withdrawn

• 1 other identifier: CHRO-2019-11
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

Preoxygenation is recommended before performing tracheal intubation. In intensive care units (ICU) patients, there is no specific recommendation regarding the duration of preoxygenation, which usually is applied for 3 to 5 minutes. Monitoring the effectiveness of preoxygenation with end-tidal oxygen concentration (EtO2) is strongly recommended in the operating room but it is never used in ICUs. The first aim of this pilot study is to assess the effect of the preoxygenation duration on EtO2, and secondarily, as an exploratory objective, to determine whether targeting a given value of EtO2 during preoxygenation might insure a safer intubation than when targeting pulse oximetry (SpO2).

Conditions

Preoxygenation; Intubation; Intensive Care Unit

Keywords

preoxygenation; intubation; end-tidal of oxygen concentration; intensive care unit; critically ill patients

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who reach an EtO2 of 90%

  To compare the percentage of patients who reach an EtO2 of 90% or higher (optimal preoxygenation) at the end of the preoxygenation period between patients randomized in the 3-min and those randomized in the 5-min preoxygenation duration group.

  3 minutes

Secondary Outcomes (8)

• Expired oxygen fraction (FeO2)

  end of the preoxygenation period

• Incidence of hypoxemia

  5 minutes after intubation

• Incidence of severe hypoxemia

  End of preoxygenation

• Incidence of severe complications

  30 minutes after intubation

• Lowest Pulsed saturation with Oxygen (SpO2)

  30 minutes after the end of preoxygenation

Study Arms (2)

3 minutes period of preoxygenation

EXPERIMENTAL

3 minutes of preoxygenation : participants in this group will receive 3 minutes of preoxygenation before intubation

Other: Preoxygenation

5 minutes period of preoxygenation

EXPERIMENTAL

5 minutes of preoxygenation: participants in this group will receive 5 minutes of preoxygenation before intubation

Other: Preoxygenation (longer)

Interventions

Preoxygenation OTHER

participants will receive 3 minutes of preoxygenation before intubation

3 minutes period of preoxygenation

Preoxygenation (longer) OTHER

participants will receive 5 minutes of preoxygenation before intubation

5 minutes period of preoxygenation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years
• Requiring intubation in ICU

You may not qualify if:

• Intubation for cardiac arrest
• End-tidal oxygen concentration monitoring not available
• Preoxygenation with high-flow nasal oxygenation
• Previous participation to the study
• Pregnancy or breastfeeding
• Lack of social security number

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (3)

CH de DAX

Dax, 40100, France

Location

CHR d'Orléans

Orléans, 45067, France

Location

CHRU de TOURS

Tours, 37000, France

Location

Related Publications (3)

• Carrillo A, Gonzalez-Diaz G, Ferrer M, Martinez-Quintana ME, Lopez-Martinez A, Llamas N, Alcazar M, Torres A. Non-invasive ventilation in community-acquired pneumonia and severe acute respiratory failure. Intensive Care Med. 2012 Mar;38(3):458-66. doi: 10.1007/s00134-012-2475-6. Epub 2012 Feb 9.

  PMID: 22318634 BACKGROUND

• Thille AW, Frat JP, Brun-Buisson C. Trends in use and benefits of non-invasive ventilation as first-line therapy in acute respiratory failure. Intensive Care Med. 2014 Aug;40(8):1179-80. doi: 10.1007/s00134-014-3370-0. Epub 2014 Jun 25. No abstract available.

  PMID: 24962719 BACKGROUND

• Ozsancak Ugurlu A, Sidhom SS, Khodabandeh A, Ieong M, Mohr C, Lin DY, Buchwald I, Bahhady I, Wengryn J, Maheshwari V, Hill NS. Use and outcomes of noninvasive positive pressure ventilation in acute care hospitals in Massachusetts. Chest. 2014 May;145(5):964-971. doi: 10.1378/chest.13-1707.

  PMID: 24480997 BACKGROUND

Study Officials

• Mai-ANh NAY, MD

  CHR Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study Randomized controlled multicenter trial Ratio 1:1

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: November 1, 2019
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)