Respiratory Variability for Respiratory Monitoring During the Postoperative Recovery Period (VariaRessPi)

University Hospital Center of Martinique

Status: Completed

Conditions: Postoperative Pulmonary Complications

Treatments: Other: Respiratory variability before and after surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04605250

19_RIPH2-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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,
• minor,
• intubated patients or with criteria of imminent intubation
• subject unable to give his free and informed consent

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Adults undergoing abdominal surgery with laparotomy

Other group

Description:

Respiratory variability before and after abdominal surgery

Treatment:

Other: Respiratory variability before and after surgery