Short- and Long-term Effects of Robot-assisted Plication in Diaphragmatic Paralysis (RAPIDLY)

April 8, 2025 updated by: Andreas Palm, Uppsala County Council, Sweden

Short- and Long-term Effects of Robot-assisted Plication in Diaphragmatic Paralysis - the Prospective RAPIDLY-study

Diaphragmatic paralysis may lead to severe symptoms such as breathlessness and reduced physical capacity.

Diaphragmatic plication using Robotic-Assisted Thoracic Surgery (RATS) is a minimally invasive surgical technique developed to improve lung function by correcting diaphragmatic elevation.

While its benefits have been reported in retrospective reports, prospective studies are lacking.

This prospective observational cohort study aimsto evaluate the short- and long-term effects of robot-assisted diaphragmatic plication on subjective breathlessness, physical performance, lung function, blood gases, and imaging findings at five Swedish university hospitals: Gothenburg, Linköping, Lund, Umeå, and Uppsala.

Patients will be assessed preoperatively and postoperatively after one to three months and after one and three years.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Assessments

Patient characteristics:

Age, sex, height, and weight will be recorded. Body mass index (BMI) is calculated by dividing a person's weight by their height in meters squared.

Aetiology of diaphragmatic paralysis, relevant co-morbidities and use of long-term oxygen therapy and/or mechanical ventilation will be recorded.

The date for symptom debut, if known, is recorded. Smoking history is defined as current smoker, ex-smoker (smoking history of ≥100 cigarettes and having quit smoking ≥6 months ago), and never smoker (smoking history of <100 cigarettes). Smoking is quantified by pack-years (the number of packs of cigarettes a person has smoked daily, multiplied by the number of years they have smoked).

Primary outcome:

The patients' exercise capacity will be evaluated using the 6-minute walking distance (6MWD). The patients are asked to walk as far as possible on a flat, straight surface for six minutes, and the total distance walked is measured.

Secondary outcomes:

Questionnaires:

The modified Borg Scale is a tool with a range from 0 to 10 used to measure an individual's perceived level of breathlessness or muscle fatigue during physical activity, where 0 represents no breathlessness, and 10 represents maximal breathlessness.

The modified Medical Research Council (mMRC) dyspnea scale is used to assess the severity of breathlessness. The scale ranges from 0 to 4, with higher scores indicating more significant breathlessness.

The Dyspnea-12 is a questionnaire used to measure the severity and quality of breathlessness in individuals with respiratory or cardiovascular conditions. It assesses dyspnea's physical and emotional aspects, providing a comprehensive picture of how breathlessness affects a person's life. It consists of 12 items, each with a scale range between 0 (no dyspnea) and 3 (severe dyspnea).

The EuroQol-5-dimension (EQ-5D) questionnaire is one of the most widely used tools for assessing health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These dimensions create a descriptive profile that can be converted into a single summary index, where a score of 1.0 indicates perfect health. Additionally, the tool includes a Visual Analog Scale (VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health), for self-assessment of overall health status.

Spirometry Spirometry will be conducted 15 minutes after bronchodilation (inhalation of 200 µg salbutamol) in both supine and upright positions. Body plethysmography and single-breath Diffusing Capacity in the Lungs for Carbon Monoxide (DLCO) measurement will be performed. Predicted values will be determined using reference equations from the Global Lung Function Initiative (GLI).

One-minute sit-to-stand test (1-MSTST) This test assesses a person's functional exercise capacity by recording the number of full sit-to-stand repetitions completed in 60 seconds.

The Maximal Inspiratory Pressure (MIP) test is a respiratory test that measures the strength of the inspiratory muscles, particularly the diaphragm. By inhaling as forcefully as possible in a handheld device, the maximum negative pressure generated is recorded.

Blood gas analysis A capillary or arterial blood gas analysis obtains the partial pressure of oxýgen and carbon dioxide (PaCO2) in kilo Pascal (kPa) and Base Excess (BE) in mmol/l. Pulse oximetry obtains oxygen saturation.

Chest X-ray Chest X-rays are acquired in full inspiration and expiration in frontal and lateral views. The distance from the most cranial part of the lung to the highest part of the diaphragm in both frontal and side views are measured separately.

Computerised tomography (CT) of Thorax A CT with a standard protocol to identify and quantify lower lobe atelectasis.

Adverse events Operating time, chest-drain duration, length of hospitalisation, per- and postoperative complications such as pain, bleeding and infections, 30-day readmission and 30-days mortality are recorded.

Statistics Descriptive statistics summarise the data, and inferential statistics compare group differences.

Associations with the outcomes will be analysed using multivariable regression models, including linear regression (for continuous outcome variables) and logistic regression (for categorical outcomes). Repeated measurements within individuals will be managed through multilevel, random-effects models.

Power calculation: Based on a standard deviation of 90 meters in the 6-minute walk test (6MWT) among the general population, and considering that the minimal clinically important difference (MCID) is 53 meters, a total of 45 patients is required.

Assessments pre-operatively Demographics Anthropometrics Co-morbidities Questionnaires Physical capacity tests Spirometry MIP Blood gas analysis Chest X-ray CT scan

Assessments 1-3 months post-operatively Anthropometrics Questionnaires Physical capacity tests Spirometry MIP Blood gas analysis Chest X-ray CT scan

Assessments after 1 and 3 years post-operatively Anthropometrics Questionnaires Physical capacity tests Spirometry MIP Blood gas analysis Chest X-ray

Ethical considerations:

Robot-assisted diaphragm plication is performed at several university hospitals in Sweden and abroad. The patients in this study have been clinically approved for this surgery. They are not exposed to any additional risks in this study beyond being examined more thoroughly with surveys and questionnaires, lung function and performance tests, and chest X-rays before and after the surgical procedure. The study is approved by the Swedish Ethical Review Authority, Dnr 2025-01028-01.

Relevance of research:

Robot-assisted plication in diaphragmatic paralysis is a new operative method performed at many thoracic centres worldwide without being scientifically evaluated in prospective studies. This national multicenter study, with a large cohort by international standards and with validated, highly relevant outcome variables, is expected to gain significant attention among thoracic surgeons and pulmonary physicians worldwide.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Uppsala, Sweden, 75185
        • Department of Medical Sciences, Lung-, Allergy-, and Sleep Research, Uppsala University/Uppsala University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with unilateral diaphragmatic paralysis

Description

Inclusion Criteria:

  • Patients with symptomatic unilateral diaphragmatic paralysis persisting for ≥1 year
  • Patients are scheduled for RATS at thoracic surgery clinics in five Swedish university hospitals (Gothenburg, Linköping, Lund, Umeå, and Uppsala).

Exclusion Criteria:

  • Inability to complete forms in Swedish
  • Neuromuscular disease as the cause of diaphragmatic paralysis
  • Other significant causes of dyspnea
  • Impaired physical capacity from other causes than diaphragmatic paralysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients accepted for Robot-assisted diaphragmatic plication
Patients with symptomatic unilateral diaphragmatic paralysis persisting for ≥1 year accepted for Robot-assisted diaphragmatic plication at 5 Swedish University Hospitals, Gothenburg, Linköping, Lund, Umeå, and Uppsala

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-minute walking distance (6MWD).
Time Frame: From enrollment to end of observation att 3 years.
The patients are asked to walk as far as possible on a flat, straight surface for six minutes, and the total distance walked is measured.
From enrollment to end of observation att 3 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The modified Borg Scale
Time Frame: From enrollment to end of observation att 3 years.
A tool with a range from 0 to 10 used to measure an individual's perceived level of breathlessness or muscle fatigue during physical activity, where 0 represents no breathlessness, and 10 represents maximal breathlessness
From enrollment to end of observation att 3 years.
The modified Medical Research Council (mMRC) dyspnea scale
Time Frame: From enrollment to end of observation att 3 years.
The mMRC is used to assess the severity of breathlessness. The scale ranges from 0 to 4, with higher scores indicating more significant breathlessness
From enrollment to end of observation att 3 years.
The Dyspnea-12 questionnaire
Time Frame: From enrollment to end of observation att 3 years.
The Dyspnea-12questionnaire is used to measure the severity and quality of breathlessness in individuals with respiratory or cardiovascular conditions. It assesses dyspnea's physical and emotional aspects, providing a comprehensive picture of how breathlessness affects a person's life. It consists of 12 items, each with a scale range between 0 (no dyspnea) and 3 (severe dyspnea)
From enrollment to end of observation att 3 years.
The EQ-5D questionnaire
Time Frame: From enrollment to end of observation att 3 years.
The EQ-5D is one of the most widely used tools for assessing health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These dimensions create a descriptive profile that can be converted into a single summary index, where a score of 1.0 indicates perfect health. Additionally, the tool includes a Visual Analog Scale (VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health), for self-assessment of overall health status
From enrollment to end of observation att 3 years.
Spirometry
Time Frame: From enrollment to end of observation att 3 years.
Spirometry will be conducted 15 minutes after bronchodilation (inhalation of 200 µg salbutamol) in both supine and upright positions. Body plethysmography and single-breath DLCO measurement will be performed. Predicted values will be determined using reference equations from the Global Lung Function Initiative
From enrollment to end of observation att 3 years.
One-minute sit-to-stand test (1-MSTST)
Time Frame: From enrollment to end of observation att 3 years.
This test assesses a person's functional exercise capacity by recording the number of full sit-to-stand repetitions completed in 60 seconds
From enrollment to end of observation att 3 years.
The Maximal Inspiratory Pressure (MIP) test
Time Frame: From enrollment to end of observation att 3 years.
MIP is a respiratory test that measures the strength of the inspiratory muscles, particularly the diaphragm. By inhaling as forcefully as possible in a handheld device, the maximum negative pressure generated is recorded
From enrollment to end of observation att 3 years.
Pulse oximetry
Time Frame: From enrollment to end of observation att 3 years.
Obtains oxygen saturation.
From enrollment to end of observation att 3 years.
Chest X-ray
Time Frame: From enrollment to end of observation att 3 years.
Chest X-rays are acquired in full inspiration and expiration in frontal and lateral views. The distance from the most cranial part of the lung to the highest part of the diaphragm in both frontal and side views are measured separately.
From enrollment to end of observation att 3 years.
Computerised tomography (CT) of Thorax
Time Frame: From enrollment to end of observation att 3 years.
A CT with a standard protocol to identify and quantify lower lobe atelectasis.
From enrollment to end of observation att 3 years.
Adverse events
Time Frame: 30 days post-operatively
Operating time, chest-drain duration, length of hospitalisation, per- and postoperative complications such as pain, bleeding and infections, 30-day readmission and 30-days mortality are recorded.
30 days post-operatively
Blood gas analysis
Time Frame: From enrollment to end of observation att 3 years.
A capillary or arterial blood gas analysis obtains the partial pressure of oxýgen (O2).
From enrollment to end of observation att 3 years.
Blood gas analysis
Time Frame: From enrollment to end of observation att 3 years.
A capillary or arterial blood gas analysis obtains the partial pressure of carbon dioxide (CO2)
From enrollment to end of observation att 3 years.
Blood gas analysis
Time Frame: From enrollment to end of observation att 3 years.
A capillary or arterial blood gas analysis obtains the levels of base excess (BE)
From enrollment to end of observation att 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala County Council, Sweden

Collaborators

Uppsala University

Investigators

  • Principal Investigator: Andreas Palm, Md, PhD, Uppsala University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

December 1, 2031

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-01028-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Partisipant Data (IPD) can be shared after an application to the Swedish Ethics Review Authority has been accepted.

Study Data/Documents

  1. Study Protocol
    Information identifier: 2025-01028-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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