Clinical trial NCT04605250: Respiratory Variability for Respiratory Monitoring During the Postoperative Recovery Period
Official title: Respiratory Variability for Respiratory Monitoring During the Postoperative Recovery Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pulmonary Complications
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Variation of the Tidal volume (Vt) between the preoperative and the postoperative period
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fort-de-France
country: Martinique
facility: CHU Martinique
Study officials:
affiliation: CHU de Martinique
name: BEN HASSEN Kais, MD
role: PRINCIPAL_INVESTIGATOR
References: