- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04605250
Respiratory Variability for Respiratory Monitoring During the Postoperative Recovery Period (VariaRessPi)
January 26, 2021 updated by: University Hospital Center of Martinique
The research consist of measuring respiratory variability of several variables of the respiratory pattern at rest and during exercise using a thoracic movement measuring technique.
The objective is to confirm the ability of this technique to measure the respiratory variability in healthy subjects comparing to flow measurements by a pneumotachograph.
In a second step, the thoracic movement technique is applied to measure respiratory variability before and after surgery in patients after abdominal surgery with laparotomy.
The objective is to observe a decrease of variability in subjects developing or at risk to develop a postoperative pulmonary complication.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The incidence of Postoperative Pulmonary Complications after non-thoracic surgery varie between 2 and 19%.
Postoperative Pulmonary Complications are associated with an increase of morbi-mortality and longer hospital stays.
However, few possibilities are available to identify Postoperative Pulmonary Complications except predictions scores and SpO2, which decreases only face to a significant lung disease.
Besides, the respiratory variability decreases during pulmonary stress situations, and is associated with an increase of mortality during mechanical ventilation.
The hypothesis is that a decrease of the respiratory variability between the preoperative and the postoperative measures is associated with an increase of Postoperative Pulmonary Complications .
However there is no mesuring tool of easy access in clinical practice.
That is why, in a first step, a thoracic sensor belt will be tested on healthy subjects.
This sensor belt is available to measure the respiratory variability.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Fort-de-France, Martinique, 97261
- CHU Martinique
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-
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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Physiological step :
- adults without any acute or chronic disease with a significant impact on daily life, particularly no cardio-respiratory disease.
- Smokers can be included.
- Free and informed consent signed.
- Clinical step :
- adults undergoing abdominal surgery with laparotomy, in emergency or scheduled,
- in Martinique and Guadeloupe.
- Free and informed oral consent.
Exclusion Criteria
- Pregnant,breast feeding women,
- minor,
- intubated patients or with criteria of imminent intubation
- subject unable to give his free and informed consent
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
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Adults undergoing abdominal surgery with laparotomy
Respiratory variability before and after abdominal surgery
|
The procedure consist of measuring thoracic chest movement and then calculating the respiratory variability reflected by the coefficient of variation in patients undergoing a surgery.
A first recording is done during preoxygenation period using as baseline for further comparisons.
(T0, 10 min) The second recording is after extubation during the postoperative recovering period, 30 minutes after interruption of sedations.
(T1, 20 min, SSPI ou SIPO) The third recording is before transferring back to classical hospitalization, 1h after T1 (20 min).
A fourth recording will be realized 24h after surgery for patients hospitalized in the post operative intensive care unit (T3, 20 min) Optional recordings may be realized if the patient is developing a postoperative respiratory complication during his hospital stay.
A follow up for maximum 7 days consisting in consulting the medical file will be realized.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variation of the Tidal volume (Vt) between the preoperative and the postoperative period
Time Frame: 7 days
|
Measure the respiratory variability in patients with abdominal surgery with laparotomy just before the anaesthetic induction and in the postoperative stage after extubation with a belt equipped with an external sensor.
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: BEN HASSEN Kais, MD, CHU de Martinique
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 (Actual)
May 21, 2019
Primary Completion (Actual)
March 12, 2020
Study Completion (Actual)
March 12, 2020
Study Registration Dates
First Submitted
July 28, 2020
First Submitted That Met QC Criteria
October 26, 2020
First Posted (Actual)
October 27, 2020
Study Record Updates
Last Update Posted (Actual)
January 27, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
April 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 19_RIPH2-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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