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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05975411
Other study ID # 18-180
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 11, 2021
Est. completion date December 15, 2023

Study information

Verified date July 2023
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pilot study in Lower Normandy concerning a total of 90 patients scheduled for a pre-anaesthesia consultation in obstetrics. These parturients who plan to give birth at the maternity hospital of the CHU will be invited to carry out their anesthesia consultation with a view to childbirth either by way of the telemedicine cabin installed in Dozulé, or by way of the telemedicine trolley installed in a center close to their place of residence, or at the CHU de Caen as usual. The validation of the adequacy of the possibilities of telemedicine with the requirements of the anesthesia consultation worked upstream is the main objective of this work, the appreciation of the parturient at this consultation, the appreciation of the consulting and validating professionals will also be collected with the aim of a maximum optimization of this new offer intended for the region.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 90
Est. completion date December 15, 2023
Est. primary completion date March 15, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pregnant woman - over 18 years old - beneficiary of social security/CMU - Non-emergency pre-anesthesia consultation - delivery planned at the maternity ward of the University Hospital of Caen - living in the vicinity of Dozulé or living near an establishment with a telemedicine cart equipped with the necessary equipment - Having received clear and honest information about the study, and having given their consent - Having given their consent for a telemedicine consultation - patient without comorbidity Exclusion Criteria: - Patient refusal - Patient under guardianship - Patient with psychomotor disability; hearing impaired; visually impaired - Difficulties in understanding information, expression; foreign language - Pathological pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Anesthesia Consultation with telemedicine
Anesthesia Consultation with telemedicine

Locations

Country Name City State
France CAEN University Hospital Caen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary assessment of the airways via a telemedicine device Composite score (rated from 5 to 14) evaluating the risk of difficult orotracheal intubation which is based on the five main elements of the airway evaluation during the anesthesia consultation which are:
Mouth opening
Mallampati score
Cervical spine mobility
Thyro-chin distance
Patient Profile
Lip test
baseline
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