NCT04760340

Brief Summary

Transesophageal Lung ultrasound (TELUS) was described for the first time in 2016. The clinical significance and benefits for the patient of the results of a TELUS examination has not been investigated to date. Since all cardiac surgery with CPB cases in adult patients are performed using a TEE probe to monitor cardiac function, a concomitant TELUS examination is possible in all cases. The study seeks to describe the incidence and severity of the modifications of the aeration of both lungs assessed by TELUS in the perioperative period of adult cardiac surgery and to establish the relation of the TELUS findings with the occurence of postoperative respiratory events (PORE). Eventually, the study will also provide results about the interobserver variation of the TELUS examination for which there no reference to date.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

January 24, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

January 24, 2021

Last Update Submit

February 15, 2021

Conditions

Cardiac Surgical Procedures

Outcome Measures

Primary Outcomes (4)

  • Extubation time (minutes)

    Time from ICU admission to first postoperative successful extubation.

    150 days

  • Total postoperative NIV time (hours)

    Total time on NIV during postoperative hospital stay

    150 days

  • Total MV time (hours)

    Total time on MV during postoperative hospital stay

    150 days

  • Total ICU stay (hours)

    Length of stay in the icu during hospital stay

    150 days

Secondary Outcomes (3)

  • Pre CPB TELUS score (n)

    1 day

  • Post CPB TELUS score (n)

    1 day

  • Post CPB P/F ratio (mmHg)

    1 day

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult cardiac surgery with CPB and TEE monitoring

You may qualify if:

  • \* Adult cardiac surgery patients with a comprehensive TEE and TELUS examination pre CPB will be included.

You may not qualify if:

  • Previous lung surgery
  • Previous thoracic radiation therapy for cancer (lung, breast, lymphoma or other)
  • Mitral valve surgery using a mini thoracotomy and video assistance
  • Use of an ultrafiltration device during CPB
  • Mechanical ventilation initiated before arrival in the OR.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.

    PMID: 22392031BACKGROUND

  • Zieleskiewicz L, Papinko M, Lopez A, Baldovini A, Fiocchi D, Meresse Z, Boussuges A, Thomas PA, Berdah S, Creagh-Brown B, Bouhemad B, Futier E, Resseguier N, Antonini F, Duclos G, Leone M. Lung Ultrasound Findings in the Postanesthesia Care Unit Are Associated With Outcome After Major Surgery: A Prospective Observational Study in a High-Risk Cohort. Anesth Analg. 2021 Jan;132(1):172-181. doi: 10.1213/ANE.0000000000004755.

    PMID: 32224722BACKGROUND

  • Cavayas YA, Girard M, Desjardins G, Denault AY. Transesophageal lung ultrasonography: a novel technique for investigating hypoxemia. Can J Anaesth. 2016 Nov;63(11):1266-76. doi: 10.1007/s12630-016-0702-2. Epub 2016 Jul 29.

    PMID: 27473720BACKGROUND

  • Litwinowicz R, Bartus K, Drwila R, Kapelak B, Konstanty-Kalandyk J, Sobczynski R, Wierzbicki K, Bartus M, Chrapusta A, Timek T, Bartus S, Oles K, Sadowski J. In-hospital mortality in cardiac surgery patients after readmission to the intensive care unit: a single-center experience with 10,992 patients. J Cardiothorac Vasc Anesth. 2015;29(3):570-5. doi: 10.1053/j.jvca.2015.01.029. Epub 2015 Jan 16.

    PMID: 26009285BACKGROUND

  • Lagier D, Fischer F, Fornier W, Huynh TM, Cholley B, Guinard B, Heger B, Quintana G, Villacorta J, Gaillat F, Gomert R, Degirmenci S, Colson P, Lalande M, Benkouiten S, Minh TH, Pozzi M, Collart F, Latremouille C, Vidal Melo MF, Velly LJ, Jaber S, Fellahi JL, Baumstarck K, Guidon C; PROVECS Study Group. Effect of open-lung vs conventional perioperative ventilation strategies on postoperative pulmonary complications after on-pump cardiac surgery: the PROVECS randomized clinical trial. Intensive Care Med. 2019 Oct;45(10):1401-1412. doi: 10.1007/s00134-019-05741-8. Epub 2019 Oct 1.

    PMID: 31576435BACKGROUND

  • Huffmyer JL, Groves DS. Pulmonary complications of cardiopulmonary bypass. Best Pract Res Clin Anaesthesiol. 2015 Jun;29(2):163-75. doi: 10.1016/j.bpa.2015.04.002. Epub 2015 Apr 23.

    PMID: 26060028BACKGROUND

  • Authors/Task Force Members; Kunst G, Milojevic M, Boer C, De Somer FMJJ, Gudbjartsson T, van den Goor J, Jones TJ, Lomivorotov V, Merkle F, Ranucci M, Puis L, Wahba A; EACTS/EACTA/EBCP Committee Reviewers; Alston P, Fitzgerald D, Nikolic A, Onorati F, Rasmussen BS, Svenmarker S. 2019 EACTS/EACTA/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Br J Anaesth. 2019 Dec;123(6):713-757. doi: 10.1016/j.bja.2019.09.012. Epub 2019 Oct 2. No abstract available.

    PMID: 31585674BACKGROUND

  • Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.

    PMID: 2868172BACKGROUND

  • Lin LI. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989 Mar;45(1):255-68.

    PMID: 2720055BACKGROUND

  • Banerjee et al. Beyond kappa : a review of interrater agreement measures. Can. J. Statistics 1999 ; 27 : 3 - 23.

    BACKGROUND

Study Officials

  • Philippe BURTIN

    Dr Philippe BURTIN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe BURTIN, MD

CONTACT

+33622745310philippe.burtin@cegetel.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesiology Department

Study Record Dates

First Submitted

January 24, 2021

First Posted

February 18, 2021

Study Start

March 1, 2021

Primary Completion

July 1, 2021

Study Completion

August 1, 2021

Last Updated

February 18, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share