Lung Ultrasound Score After ENT Cancer Surgery

Surgery Clinical Trial

— LUSENT  

Official title:

Lung Ultrasound Score After Ear, Nose and Throat Cancer Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05482841
• Other study ID #: LUSENT
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Centre Leon Berard
• Contact: Grégoire Wallon, MD
• Phone: +33 (0) 4 78 78 27 53
• Email: gregoire.wallon[@]lyon.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

After ENT cancer surgery, postoperative respiratory complications are common, especially after tracheostomy.

Problems with lung ventilation called "atelectasis" are largely associated with these complications. These atelectasis develop within minutes of the start of general anesthesia. Patients who develop a complication require longer postoperative oxygen treatment and more physical therapy.

The diagnosis of atelectasis can be made by standard chest radiography, which is a source of radiation and requires moving the patient. An alternative technique, lung ultrasound, is a non-irradiating examination that can be performed in the patient's bed. It is routinely performed in the postoperative surveillance room and in the intermediate care unit at the Centre Léon Bérard.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ENT cancer surgery with tracheostomy or tracheotomy

Exclusion Criteria:

• under 18 years old

• deprivation of liberty

• pre-existing tracheotomy or tracheostomy

• patient refusal

Related Conditions & MeSH terms

• Cancer of Head and Neck
• Head and Neck Neoplasms
• Postoperative Pulmonary Complication
• Surgery
• Tracheostomy

Intervention

Diagnostic Test:
• Lung ultrasound score
To evaluate the incidence of pulmonary atelectasis in the post-anesthesia care unit (PACU) using lung ultrasound.

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon	Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lung ultrasound score, on day 2 after ENT cancer surgery.	Lung ultrasound score : Images were obtained on day 2 after PACU (in intermediate care unit). 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.	on the 2nd day after surgery
Secondary	Lung ultrasound score, on day 1 after ENT cancer surgery.	Lung ultrasound score : Images were obtained on day 1 after PACU (in intermediate care unit). 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.	on the 1st day after surgery
Secondary	To assess the incidence of pulmonary atelectasis in the PACU by chest radiography.	pulmonary atelectasis on chest radiography	Up to 24 hours
Secondary	Study gas exchange in PACU	SpO2/FiO2	up to 24 hours
Secondary	Study gas exchange on day 1 after surgery	SpO2/FiO2	on the 1st day after surgery
Secondary	Study gas exchange on day 2 after surgery	SpO2/FiO2	on the 2nd day after surgery
Secondary	incidence of postoperative respiratory complications in the month following ENT cancer surgery (eg number of participants with a postoperative respiratory complication)	number of participants who had a postoperative respiratory complication within 30 days of surgery: atelectasis, pulmonary oedema, consolidation, pneumothorax, pleural effusion, bronchospasm, pneumonia.	up to 31 days