Cancer of Head and NeckLUSENTNCT05482841
Lung Ultrasound Score After ENT Cancer Surgery
An observational study of Cancer of Head and Neck and Tracheostomy, run by Centre Leon Berard at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Head and Neck, Tracheostomy, Postoperative Pulmonary Complication
- What is being tested?
- Lung ultrasound score
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2022to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ENT cancer surgery patients
Who may be able to join
- ENT cancer surgery with tracheostomy or tracheotomy
Who cannot join
- under 18 years old
- deprivation of liberty
- pre-existing tracheotomy or tracheostomy
- patient refusal
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Léon Bérard
Lyon, Rhône, 69008
Grégoire Wallon, +33 (0) 4 78 78 27 53, gregoire.wallon@lyon.unicancer.fr
About this study
Official title: Lung Ultrasound Score After Ear, Nose and Throat Cancer Surgery
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.
Read the 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.
- Being tested
- Lung ultrasound score
- Keywords
- Postoperative pulmonary complication, Lung ultrasound, Tracheostomy, ENT cancer surgery
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasound scoreDiagnostic test
To evaluate the incidence of pulmonary atelectasis in the post-anesthesia care unit (PACU) using lung ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| ENT cancer surgery patients | all patients undergoing ENT cancer surgery with tracheotomy or tracheostomy at the Centre Léon Bérard. Receives: Diagnostic Test: Lung ultrasound score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 hours
Secondary outcomes (7)
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.
Measured: on the 2nd day after surgery
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.
Measured: on the 1st day after surgery
To assess the incidence of pulmonary atelectasis in the PACU by chest radiography.
pulmonary atelectasis on chest radiography
Measured: Up to 24 hours
Study gas exchange in PACU
SpO2/FiO2
Measured: up to 24 hours
Study gas exchange on day 1 after surgery
SpO2/FiO2
Measured: on the 1st day after surgery
Study gas exchange on day 2 after surgery
SpO2/FiO2
Measured: on the 2nd day after surgery
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.
Measured: up to 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Dec 2022
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cancer of Head and NeckStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482841
- Sponsor's protocol ID
- LUSENT
- Acronym
- LUSENT
- Status last verified
- Feb 2024
- First submitted
- 23 Jun 2022
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32800584Touw 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.
PubMed 29529332Zieleskiewicz 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.
PubMed 32224722Monastesse 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.
PubMed 27669555
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound Score After Ear, Nose and Throat Cancer Surgery
- ClinicalTrials.gov ID
- NCT05482841
- Acronym / sponsor ID
- LUSENT / LUSENT
- Keywords
- Postoperative pulmonary complication, Lung ultrasound, Tracheostomy, ENT cancer surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ENT cancer surgery patients | – | Diagnostic Test: Lung ultrasound scoreall patients undergoing ENT cancer surgery with tracheotomy or tracheostomy at the Centre Léon Bérard. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ENT cancer surgery patients
Key inclusion criteria (1 listed)
- ENT cancer surgery with tracheostomy or tracheotomy
Key exclusion criteria (4 listed)
- under 18 years old
- deprivation of liberty
- pre-existing tracheotomy or tracheostomy
- patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung ultrasound scoreTo evaluate the incidence of pulmonary atelectasis in the post-anesthesia care unit (PACU) using lung ultrasound. | Diagnostic test | ENT cancer surgery patients |
Primary outcome
Lung ultrasound score, in the PACU after ENT cancer surgery.
Time frame: Up to 24 hours
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.
7 secondary outcomes
Lung ultrasound score, on day 2 after ENT cancer surgery.
Time frame: on the 2nd day after surgery
Lung ultrasound score, on day 1 after ENT cancer surgery.
Time frame: on the 1st day after surgery
To assess the incidence of pulmonary atelectasis in the PACU by chest radiography.
Time frame: Up to 24 hours
Study gas exchange in PACU
Time frame: up to 24 hours
Study gas exchange on day 1 after surgery
Time frame: on the 1st day after surgery
Study gas exchange on day 2 after surgery
Time frame: on the 2nd day after surgery
incidence of postoperative respiratory complications in the month following ENT cancer surgery (eg number of participants with a postoperative respiratory complication)
Time frame: up to 31 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Background: PubMed 32800584Goel 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.
- Background: PubMed 29529332Touw 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.
- Background: PubMed 32224722Zieleskiewicz 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.
- Background: PubMed 27669555Monastesse 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Head and Neck and Tracheostomy, run by Centre Leon Berard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grégoire Wallon, MD (+33 (0) 4 78 78 27 53, gregoire.wallon@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung ultrasound score, in the PACU after ENT cancer surgery. (time frame: Up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05482841, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.