Skip to content

Respiratory Variability for Respiratory Monitoring During the Postoperative Recovery Period

Respiratory Variability for Respiratory Monitoring During the Postoperative Recovery Period

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04605250
Acronym
VariaRessPi
Enrollment
50
Registered
2020-10-27
Start date
2019-05-21
Completion date
2020-03-12
Last updated
2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pulmonary Complications

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.

Interventions

OTHERRespiratory variability before and after surgery

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.

Sponsors

University Hospital Center of Martinique
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Variation of the Tidal volume (Vt) between the preoperative and the postoperative period7 daysMeasure 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.

Countries

Martinique

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026