Respiratory Variability for Respiratory Monitoring During the Postoperative Recovery Period

Not Applicable

Completed

• Conditions: Postoperative Pulmonary Complications
• Interventions: Other: Respiratory variability before and after surgery

• Registration Number: NCT04605250
• Lead Sponsor: University Hospital Center of Martinique

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.

Study Timeline

• Study Start: 2019-05-21
• Primary Completion: 2020-03-12
• Study Completion: 2020-03-12
• Status Verified: 2020-04
• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-10-27
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adults undergoing abdominal surgery with laparotomy	Respiratory variability before and after surgery	Respiratory variability before and after abdominal surgery

Primary Outcome Measures

Name	Time	Method
Variation of the Tidal volume (Vt) between the preoperative and the postoperative period	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.

Trial Locations

Locations (1)

CHU Martinique; 🇲🇶 Fort-de-France, Martinique