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NCT Number: NCT06486168

Incidence of Diaphragmatic Dysfunction After Non-Intubated Video-Assisted Thoracoscopic Surgery

The objective of this this single-center prospective longitudinal study is to evaluate the incidence of diaphragmatic dysfunction after non-intubated video-assisted thoracoscopic surgery (NIVATS).

Participant will be evaluated during surgery, 2 hours and 24 hours after surgery.

Recruiting

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Key information

Conditions

Diaphragmatic Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This is a prospective longitudinal single-center study conducted on patients undergoing non-intubated video-assisted thoracoscopic surgery. The main indications for this surgery are wedge resections, pneumothorax repair, and pleural biopsies (with or without talc pleurodesis) for pleural effusion.

Except for the inclusion visit, each patient will be evaluated twice, 2 and 24 hours after the end of the surgical procedure. The data from each evaluation will be recorded by the physician in the electronic CRF

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient aged 18 years or older
  • Patient who has read and signed the informed consent form for participation in the study
  • Patient undergoing surgery with video-assisted thoracoscopic surgery without intubation

Exclusion criteria

  • Known or detected diaphragmatic dysfunction before the intervention
  • Patient not affiliated with the French social security system
  • Patient under legal protection, guardianship, or curatorship
  • Patient already enrolled in another therapeutic study protocol (involving medications or non-drug therapies)
  • Patient in an exclusion period from a previous clinical study
  • Mental deficiency or any other reason that may hinder understanding or strict adherence to the protocol

Treatment and study plan

NIVATS

Procedure

Non-Intubated Video-Assisted Thoracic Surgery (NIVATS) is the least invasive approach available. It is part of an optimal Enhanced Recovery After Surgery (ERAS) pathway and allows for expanding surgical indications in patients with poor cardio-pulmonary function.

Primary outcomes

  1. Diaphragmatic excursion

    Time frame: Hour 24

    The measurement of diaphragmatic excursion at H2 and H24 constitutes the primary evaluation criterion. Diaphragmatic excursion will be measured by ultrasound using a low-frequency probe (< 5 MHz), either an abdominal or cardiac probe, positioned under the costal margin on the operated side and the contralateral side. To limit inter-operator variability, the patient's ultrasound evaluation will, as much as possible, be performed by the same operator. The presence of diaphragmatic dysfunction is defined by a diaphragmatic excursion of less than 1 cm.

Secondary outcomes

  1. Pain evaluation

    Time frame: Hour 2

    Pain will be assessed using a simple numeric scale ranging from 0 (no pain) to 10 (worst pain ever experienced).

  2. Pain evaluation

    Time frame: Hour 24

    Pain will be assessed using a simple numeric scale ranging from 0 (no pain) to 10 (worst pain ever experienced).

  3. Diaphragmatic thickening evaluation

    Time frame: Hour 2

    Diaphragmatic thickening will be measured by ultrasound and will be assessed in relation to the baseline thickness and the contralateral diaphragmatic thickness

  4. Diaphragmatic thickening evaluation

    Time frame: Hour 24

    Diaphragmatic thickening will be measured by ultrasound and will be assessed in relation to the baseline thickness and the contralateral diaphragmatic thickness

  5. postoperative complications evaluation

    Time frame: Hour 2

    The screening for hypoxemia using a pulse oximeter will be conducted continuously throughout the study duration.

    Cardiovascular events will be evaluated based on the time to the occurrence of one of the 3 major cardiac events comprising the composite endpoint MACE (Major Adverse Cardiac Events): cardiovascular death, non-fatal myocardial infarction, non-fatal stroke.

  6. postoperative complications evaluation

    Time frame: Hour 24

    The screening for hypoxemia using a pulse oximeter will be conducted continuously throughout the study duration.

    Cardiovascular events will be evaluated based on the time to the occurrence of one of the 3 major cardiac events comprising the composite endpoint MACE (Major Adverse Cardiac Events): cardiovascular death, non-fatal myocardial infarction, non-fatal stroke.

Study contacts

Contact information is provided by the study sponsor or research team.

Karim GUESSOUS, MD

CONTACT

Nabil ZANOUN, MD

CONTACT

[email protected]

01 69 39 15 53 ext. 33

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

Incidence of Diaphragmatic Dysfunction After Non-Intubated Video-Assisted Thoracoscopic Surgery.

Acronym: DYNASTY

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 3, 2024
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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