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RecruitingNCT06133777RESPIVARIAUpdated Aug 20, 2026

Respiratory Variability and Postoperative Complications During Thoracic Lung Resection.

An interventional study of Respiratory variability monitoring in Lung Injury, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Postoperative respiratory complications (PRC) represent a major public health issue. Majority of PRCs occur once the patient leaves the post-interventional monitoring room.

Identifying patients at risk for PRC is therefore an important step for improving their post-operative care. In this context, any clinical marker making it possible to detect early alteration of the respiratory state in the postoperative phase deserves to be evaluated.

This study is based on the hypothesis that measuring indices of respiratory variability which is synonymous with "good respiratory health" can be part of these markers.

The measurement of respiratory variability will be done in patients with thoracic lung resection surgery before anesthetic induction and in the postoperative phase after extubation. It will be measured using a belt equipped with an external sensor allowing automatic and continuous analysis of thoracic movement by frequency analysis

Read the detailed description

Postoperative respiratory complications (PRC) represent a major public health issue. By PRC, we mean acute respiratory distress, bronchospasm, pleural effusion, respiratory infection, atelectasis, aspiration pneumonia and pneumothorax.

Postoperative respiratory dysfunction reaches its peak in the 48 hours following surgery. Majority of PRCs therefore occur once the patient leaves the post-interventional monitoring room.

Identifying patients at risk for PRC is an important step for improving their post-operative care. For this, there are predictive scores, notably the ARISCAT score, pre-operatively. However, there are few measurement methods to detect early alteration of the respiratory state in the postoperative phase. Therefore, the physician in charge of the patient is alerted late if the patient deteriorates on the respiratory plan.

In this context, any clinical marker making it possible to detect early alteration of the respiratory state in the postoperative phase deserves to be evaluated. Therefore, this study is based on the hypothesis that measuring indices of respiratory variability can be part of these markers. Consequently, this research which aims to describe these indices of respiratory variability is of major interest.

Respiratory variability is synonymous with "good respiratory health". By the opposite, the reduction of this same variability is pathological and indicates an increase in the level of load imposed on the respiratory system.

The measurement of respiratory variability will be done in patients with thoracic lung resection surgery before anesthetic induction and in the postoperative phase after extubation. It will be measured using a belt equipped with an external sensor allowing automatic and continuous analysis of thoracic movement by frequency analysis

02

Conditions studied

  • Lung Injury

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03

In context

Lung Injury

114 studies on the registry are indexed under Lung Injury; 33 are open to participants now.

This study's planned enrollment of 60 is close to the median of 62 across 75 interventional studies indexed under Lung Injury.

Browse Lung Injury studies →

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 207 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient, man or woman, who signed
  • Patient older than 18 years old
  • Patient admitted for planned thoracic resection surgery (lobectomy, bi-lobectomy, pneumonectomy) whatever the etiology is

Exclusion criteria

Exclusion Criteria:

- None (medical aspects)

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Respiratory Variability Monitoring

    Respiratory variability will be measured using a belt equipped with an external sensor allowing automatic and continuous analysis of thoracic movement by frequency analysis

    Other: Respiratory variability monitoring

Interventions

  • OtherRespiratory variability monitoring

    Respiratory variability will be measured using a belt equipped with an external sensor allowing automatic and continuous analysis of thoracic movement by frequency analysis

06

What researchers measure

Primary outcomes

  1. Coefficient of variation

    Each respiratory cycle is defined by an inspiratory time followed by an expiratory time. Ordinary, it is observed a variability compared to the previous cycle in terms of amplitude and temporality. Coefficient of variation is one of the parameters able to measure this respiratory variability.

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2024 (actual). Primary completion is estimated for Sep 2026, 23 months after the start.

Of 28 interventional studies with no phase under Lung Injury, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 69. This study's planned 23 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2023
First posted
Nov 15, 2023
StartActual
Oct 28, 2024
Primary completionEst.
Sep 30, 2026
CompletionEst.
Sep 30, 2026
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06133777
Responsible party
Sponsor
First posted
Nov 15, 2023
Start date
Oct 28, 2024
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Aug 20, 2026

Study contacts

Kais BEN HASSEN, MD
Contact
kais.benhassen@gmail.com
+33491171421
Kais BEN HASSEN, MD
principal investigator · Hôpital privé de Clairval

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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