Pre and postoperative analysis of voice as a marker of respiratory function
| ISRCTN | ISRCTN50550162 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50550162 |
| Sponsor | National and Kapodistrian University of Athens |
| Funder | Investigator initiated and funded |
- Submission date
- 11/11/2025
- Registration date
- 12/11/2025
- Last edited
- 28/11/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
The aim of this study is to analyze the voice recording of patients 18-64 years old receiving general anesthesia pre and postoperatively using artificial intelligence, in order to determine whether it correlates with changes in pulmonary function following general anesthesia, endotracheal intubation, and mechanical ventilation during surgery.
Who can participate?
The study will include 100 male and female patients aged 18 to 65 years who are scheduled to undergo surgical procedures under general anesthesia.
What does the study involve?
Patients' voice will be recorded before surgery, as well as at 1, 6, and 24 hours postoperatively.
Oxygen saturation and the duration of surgery will also be recorded
What are the possible benefits and risks of participating?
Benefits: personalized assessment of pulmonary function based on voice recording and SpO2 measurements
Risks: surgery-related risks
Where is the study run from?
1st Department of Anesthesiology, Aretaieion University Hospital (Greece)
When is the study starting and how long is it expected to run for?
The study is expected to start recruiting patients on the 1st of December 2025 and is expected to complete 100 patients on the 30th of June 2026
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Aliki Tympa, MD, PhD, Assistant Professor of Anesthesiology, National and Kapodistrian University of Athens
alikitympa@med.uoa.gr
Contact information
Public, Scientific, Principal investigator
Faculty of Medicine
National and Kapodistrian University of Athens
Aretaieion University Hospital
76 Vasilissis Sofias Avenue
Athens
11528
Greece
| Phone | +30 (0)2107286195 |
|---|---|
| alikitympa@med.uoa.gr |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single centered, cross-sectional analytical study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Voice as a biomarker of respiratory function pre and postoperatively |
| Study objectives | The aim of this study is to analyze the patient’s voice preoperatively and compare it with his voice postoperatively using artificial intelligence, in order to determine whether it correlates with changes in pulmonary function following general anesthesia, endotracheal intubation, and mechanical ventilation during surgery |
| Ethics approval(s) |
Approved 24/07/2025, Aretaieion University Hospital Ethics Committee (76 Vas.Sofias avenue, Athens, 11528, Greece; +30 2107286130; bxeir@med.uoa.gr), ref: 705/24-07-2025 |
| Health condition(s) or problem(s) studied | Prevention of respiratory dysfunction in patients who received general anesthesia |
| Intervention | Participants voices are recorded pre and post-operatively and analyzed with an artificial intelligence voice analyzer. Patients are then subjected to various operations. Their oxygen saturation levels are measured pre- and postoperatively through a pulse oxymeter (non-invasive monitoring). Observation begins on the morning of the scheduled operation and at 1, 6 and 24 hours postoperatively. There is no further follow up beyond the 24hour time period. |
| Intervention type | Other |
| Primary outcome measure(s) |
Alterations in voice recordings measured through an artificial intelligence program pre and post-operatively |
| Key secondary outcome measure(s) |
Oxygen saturation measured through pulse oxymeter pre and post operatively. |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | Patients 18-65 years old receiving general anesthesia |
| Key exclusion criteria | Vocal cord paralysis |
| Date of first enrolment | 01/12/2025 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- Greece
Study participating centre
Athens
11528
Greece
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during an/or analysed during the current study will be available upon request (Assistant Professor A.Tympa, email: alikitympa@med.uoa.gr |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/11/2025: Contact details updated.
12/11/2025: Trial's existence confirmed by Aretaieion University Hospital Ethics Committee.
