Clinical trial NCT05482841: Lung Ultrasound Score After ENT Cancer Surgery
Official title: Lung Ultrasound Score After Ear, Nose and Throat Cancer Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer of Head and Neck
Tracheostomy
Postoperative Pulmonary Complication
Surgery
Keywords: Postoperative pulmonary complication
Lung ultrasound
Tracheostomy
ENT cancer surgery
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ENT cancer surgery patients

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Lung ultrasound score, in the PACU after ENT cancer surgery.
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Lung ultrasound score, on day 2 after ENT cancer surgery.
timeFrame: on the 2nd day after surgery
measure: Lung ultrasound score, on day 1 after ENT cancer surgery.
timeFrame: on the 1st day after surgery
measure: To assess the incidence of pulmonary atelectasis in the PACU by chest radiography.
timeFrame: Up to 24 hours
measure: Study gas exchange in PACU
timeFrame: up to 24 hours
measure: Study gas exchange on day 1 after surgery
timeFrame: on the 1st day after surgery
measure: Study gas exchange on day 2 after surgery
timeFrame: on the 2nd day after surgery
measure: incidence of postoperative respiratory complications in the month following ENT cancer surgery (eg number of participants with a postoperative respiratory complication)
timeFrame: up to 31 days
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
state: Rhône
Study officials:
References:
citation: 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.
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.
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.
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.