Lung Ultrasound Score After ENT Cancer Surgery

NCT05482841 | Recruiting

• 1 other identifier: LUSENT
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

After ENT cancer surgery, postoperative respiratory complications are common, especially after tracheostomy. The objective of this study is to characterize the pulmonary status of patients after ENT cancer surgery. We wish to collect and analyze the pulmonary abnormalities revealed by the ultrasound scans performed in the post-anesthesia care unit (PACU), at day 1 and at day 2 after ENT cancer surgery with tracheostomy.

Conditions

Cancer of Head and Neck; Tracheostomy; Postoperative Pulmonary Complication; Surgery

Keywords

Postoperative pulmonary complication; Lung ultrasound; Tracheostomy; ENT cancer surgery

Outcome Measures

Primary Outcomes (1)

• Lung ultrasound score, in the PACU after ENT cancer surgery.

  Lung ultrasound score : Images were obtained in PACU. Care was taken to set the focal zone on the pleural line. The thorax was divided into 12 quadrants: anterior, lateral, and posterior zones (separated by the anterior and posterior axillary lines) each divided in upper and lower portions for the right and left lung. Intercostal spaces of each of these areas were scanned and a cine-loop of the most pathologic area of each quadrant was saved to digital format. A semiquantitative score, the lung ultrasound (LUS) score, was calculated to assess lung aeration at each time point as described by Monastesse.

  Up to 24 hours

Secondary Outcomes (7)

• Lung ultrasound score, on day 2 after ENT cancer surgery.

  on the 2nd day after surgery

• Lung ultrasound score, on day 1 after ENT cancer surgery.

  on the 1st day after surgery

• To assess the incidence of pulmonary atelectasis in the PACU by chest radiography.

  Up to 24 hours

• Study gas exchange in PACU

  up to 24 hours

• Study gas exchange on day 1 after surgery

  on the 1st day after surgery

Study Arms (1)

ENT cancer surgery patients

all patients undergoing ENT cancer surgery with tracheotomy or tracheostomy at the Centre Léon Bérard.

Diagnostic Test: Lung ultrasound score

Interventions

Lung ultrasound score DIAGNOSTIC_TEST

To evaluate the incidence of pulmonary atelectasis in the post-anesthesia care unit (PACU) using lung ultrasound.

ENT cancer surgery patients

Eligibility Criteria

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

Study Population

ENT cancer surgery patients

You may qualify if:

• ENT cancer surgery with tracheostomy or tracheotomy

You may not qualify if:

• under 18 years old
• deprivation of liberty
• pre-existing tracheotomy or tracheostomy
• patient refusal

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, Rhône, 69008, France

RECRUITING

Related Publications (4)

• Goel N, Sen IM, Bakshi J. Lung ultrasonography as a tool to guide perioperative atelectasis treatment bundle in head and neck cancer patients undergoing free flap reconstructive surgeries: a preliminary observational study. Braz J Otorhinolaryngol. 2022 Mar-Apr;88(2):204-211. doi: 10.1016/j.bjorl.2020.05.030. Epub 2020 Jul 29.

  PMID: 32800584 BACKGROUND

• Touw HR, Parlevliet KL, Beerepoot M, Schober P, Vonk A, Twisk JW, Elbers PW, Boer C, Tuinman PR. Lung ultrasound compared with chest X-ray in diagnosing postoperative pulmonary complications following cardiothoracic surgery: a prospective observational study. Anaesthesia. 2018 Aug;73(8):946-954. doi: 10.1111/anae.14243. Epub 2018 Mar 12.

  PMID: 29529332 BACKGROUND

• 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: 32224722 BACKGROUND

• Monastesse A, Girard F, Massicotte N, Chartrand-Lefebvre C, Girard M. Lung Ultrasonography for the Assessment of Perioperative Atelectasis: A Pilot Feasibility Study. Anesth Analg. 2017 Feb;124(2):494-504. doi: 10.1213/ANE.0000000000001603.

  PMID: 27669555 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Grégoire Wallon, MD

CONTACT

+33 (0) 4 78 78 27 53; gregoire.wallon@lyon.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: August 1, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)