Respiratory Variability for Respiratory Monitoring During the Postoperative Recovery Period

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.

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Key information

Conditions

Postoperative Pulmonary Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Martinique

Fort-de-France, 97261, Martinique

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respiratory variability before and after surgery

Other

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.

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.

Sponsors and collaborators

Lead sponsor

University Hospital Center of Martinique

Other

Registry information

Acronym: VariaRessPi

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Oct 27, 2020
Registry last updated: Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed