CATmedO: Telemedicine Anesthesia Consultation, Pilot Study in Obstetrics.

Sponsor
University Hospital, Caen (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05975411
Collaborator
(none)
90
1
35.1
2.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Anesthesia Consultation with telemedicine

Study Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Telemedicine Anesthesia Consultation, Pilot Study in Obstetrics.
Actual Study Start Date :
Jan 11, 2021
Actual Primary Completion Date :
Mar 15, 2021
Anticipated Study Completion Date :
Dec 15, 2023

Arms and Interventions

Arm Intervention/Treatment
telemedecine cabin

Anesthesia Consultation with telemedicine cabin installed in Dozulé

Other: Anesthesia Consultation with telemedicine
Anesthesia Consultation with telemedicine

telemedicine trolley

Anesthesia Consultation with telemedicine by way of the telemedicine trolley installed in a center close to their place of residence

Other: Anesthesia Consultation with telemedicine
Anesthesia Consultation with telemedicine

standard

Anesthesia Consultation at the CHU de Caen as usual.

Outcome Measures

Primary Outcome Measures

  1. assessment of the airways via a telemedicine device [baseline]

    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

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CAEN University Hospital Caen France

Sponsors and Collaborators

  • University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT05975411
Other Study ID Numbers:
  • 18-180
First Posted:
Aug 3, 2023
Last Update Posted:
Aug 3, 2023
Last Verified:
Jul 1, 2023
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2023