Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05695404
Other study ID # THOR-02-2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 28, 2020
Est. completion date October 5, 2021

Study information

Verified date January 2023
Source Institut Mutualiste Montsouris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the present work was to evaluate if the presence on the operating field of a 3D printed personalized model of the pulmonary anatomy of a patient operated by full thoracoscopy for an anatomical segmentectomy, makes it possible to reduce the mental workload and the fatigue of the surgeon.


Description:

Between 28.10.2020 and 05.10.2021, we successively included all anatomic segmentectomies performed by full thoracoscopy in our department, except for S6 segmentectomies, S4+5 left bisegmentectomy and patients for whom the time to surgery was considered too short to obtain the 3D printed model before surgery. We performed a prospective randomized controlled pilot trial on 2 parallel arms: - The "Digital" arm - The "Digital+Object" arm.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date October 5, 2021
Est. primary completion date October 5, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - all anatomic segmentectomies performed by full thoracoscopy, except for S6 segmentectomies, S4+5 left bisegmentectomy and patients for whom the time to surgery was considered too short to obtain the 3D printed model before surgery. Exclusion Criteria: - S6 segmentectomies - S4+5 left bisegmentectomy - Patients for whom the time to surgery was considered too short to obtain the 3D printed model before surgery.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Segmentectomy
Lung resection

Locations

Country Name City State
France Institut Mutualiste Montsouris (thoracic surgery department) Paris

Sponsors (3)

Lead Sponsor Collaborator
Institut Mutualiste Montsouris Fondation de l'Avenir, Paris cite university, 75006 Paris, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Surgeon's mental workload. measure of mental workload by the NASA-TLX score at the end of the surgery: It is a multidimensional rating scale that has six bipolar dimensions: mental demand (MD); physical demand (PD); time demand (TD); self performance (P); effort (E); and frustration (F). The dimensions thus reflect tasks (DM, PD, TD), performance (P), and behavioral factors (E and F). NASA-TLX is calculated through a self-questionnaire, using 20-point visual analogue scales anchored by very low and very high. The test provides a global load score between zero and 100 and by sub-dimensions, higher scores indicating higher mental loads of subjective perceptions. 1 day
Secondary The surgeon's stress during surgery To assess stress, the surgeon wore a Holter device throughout the surgical procedure 1 day
Secondary Surgeon's attention to work by d2-R test For the evaluation of the surgeon's attention to work at the end of the surgery, we used first d2-R test.
Scoring of the d2-R test included the following: concentration performance (CC), which represents the capacity of concentration; total number of target items processed, included the omitted ones (CCT), which informs about the speed of processing the test; percentage of errors (E%) which is defined as (total number of errors x 100)/CCT, and reflects performance accuracy.
These scores are standardized to standard score (NS), used by default for the computerized d2-R. The NS ranges from 20 to 80, with an average of 50. In the normal distribution scale of the d2-R test, 7% of the normative subjects scored under 35, 24% scored between 35 and 44, 38% scored between 45 and 55, 24% scored from 56 to 65 and 7% scored over 65. The scores are consider very weak, weak, mean, high and very high, respectively.
1 day
Secondary Surgeon's attention to work by EncephalApp Stroop test. For the evaluation of the surgeon's attention to work at the end of the surgery, we used also EncephalApp Stroop test.
The task has two components: "off" and "on" states. In the "off " state, the surgeon views a pound signs (###) presented in red, green, or blue, one at a time and has to respond as quickly as possible by touching the matching color of the stimulus to the colors displayed at the bottom of the screen. In the "on" state the subject has to accurately select the color of the word presented, which is actually the name of the color in discordant coloring. The specific outcomes of the EncephalApp Stroop test were: the total time for five correct runs in the "off " state (OffTime) and in the "on" state (OnTime); the number of runs needed to complete the five correct "off" runs and five correct "on" runs.
1 day
Secondary The surgeon's overall satisfaction at the end of the surgery. To assess surgeon subjective satisfaction at the end of the surgery, we used a subjective satisfaction 5-point Likert scale 1 day
Secondary Duration of the surgical procedure calculated from the skin incision to the completion of the segmentectomy 1 day
See also
  Status Clinical Trial Phase
Recruiting NCT04865874 - GDT-PPV Protocol in Thoracic Surgery N/A
Active, not recruiting NCT02715271 - Study of TB Lesions Obtained in Therapeutical Surgery
Completed NCT02919267 - Physiology of Lung Collapse Under One-Lung Ventilation: Underlying Mechanisms N/A
Completed NCT02964026 - Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients N/A
Recruiting NCT03165539 - Cerebral Oxygen Desaturation and Post-Operative Delirium in Thoracic Surgical Patients
Terminated NCT01320475 - Epidural Levobupivacaine-sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine Phase 4
Recruiting NCT05045196 - Health-promoting Family Conversations and Open Heart Surgery N/A
Completed NCT04507958 - Electronic Stethoscope Use During Intubation in Full Personal Protective Equipment
Recruiting NCT05060302 - Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery N/A
Completed NCT05667467 - The Effect of Care Bundle in Heart Surgery N/A
Not yet recruiting NCT03275428 - THRIVE and Non-intubated Thoracic Surgery N/A
Not yet recruiting NCT05482230 - Application of Tracheal Intubation in Lateral Position in Thoracic Surgery N/A
Enrolling by invitation NCT04429009 - A Randomized Control Trial of ZEPHYRx Gamified Incentive Spirometry Compared to Traditional Spirometry N/A
Not yet recruiting NCT03628040 - Erector Spinae Plane Block for Video-assisted Thoracoscopic Surgery Phase 3
Recruiting NCT03300622 - Assessment in Patients After Thoracic Surgery N/A
Completed NCT00981474 - Cerebral Autoregulation Monitoring During Cardiac Surgery N/A
Completed NCT03309280 - Influence of Different Parameters on Extubation Time After Cardiac Surgery.
Recruiting NCT03820700 - Using Hypnosis and Virtual Reality During Pre and Postoperative Cardiovascular Surgery. N/A
Completed NCT03768193 - Deep Serratus Anterior Plane Block vs Surgically-placed Paravertebral Block for VATS Surgery N/A
Recruiting NCT04609228 - Cardiac Surgery Outcomes in Blood-transfusion Acceptors and no Acceptors