LUSENT: Lung Ultrasound Score After ENT Cancer Surgery

Sponsor
Centre Leon Berard (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05482841
Collaborator
(none)
80
1
17
4.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Lung ultrasound score

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

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Lung Ultrasound Score After Ear, Nose and Throat Cancer Surgery
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
ENT cancer surgery patients

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

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

Outcome Measures

Primary Outcome Measures

  1. Lung ultrasound score, on day 2 after ENT cancer surgery. [on the 2nd day after 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.

Secondary Outcome Measures

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

  2. Lung ultrasound score, on day 1 after ENT cancer surgery. [on the 1st day after 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.

  3. To assess the incidence of pulmonary atelectasis in the PACU by chest radiography. [Up to 24 hours]

    pulmonary atelectasis on chest radiography

  4. Study gas exchange in PACU [up to 24 hours]

    SpO2/FiO2

  5. Study gas exchange on day 1 after surgery [on the 1st day after surgery]

    SpO2/FiO2

  6. Study gas exchange on day 2 after surgery [on the 2nd day after surgery]

    SpO2/FiO2

  7. incidence of postoperative respiratory complications in the month following ENT cancer surgery (eg number of participants with a postoperative respiratory complication) [up to 31 days]

    number of participants who had a postoperative respiratory complication within 30 days of surgery: atelectasis, pulmonary oedema, consolidation, pneumothorax, pleural effusion, bronchospasm, pneumonia.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Léon Bérard Lyon Rhône France 69008

Sponsors and Collaborators

  • Centre Leon Berard

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT05482841
Other Study ID Numbers:
  • LUSENT
First Posted:
Aug 1, 2022
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Leon Berard
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2022