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Clinical Trials/NCT04605250
NCT04605250
Completed
N/A

Respiratory Variability for Respiratory Monitoring During the Postoperative Recovery Period

University Hospital Center of Martinique1 site in 1 country50 target enrollmentMay 21, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Postoperative Pulmonary Complications
Sponsor
University Hospital Center of Martinique
Enrollment
50
Locations
1
Primary Endpoint
Variation of the Tidal volume (Vt) between the preoperative and the postoperative period
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
May 21, 2019
End Date
March 12, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital Center of Martinique
Responsible Party
Sponsor

Eligibility Criteria

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,

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Study Sites (1)

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