Respiratory Variability for Respiratory Monitoring During the Postoperative Recovery Period

NCT04605250 | Completed

• 1 other identifier: 19_RIPH2-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pulmonary Complications

Outcome Measures

Primary Outcomes (1)

• Variation of the Tidal volume (Vt) between the preoperative and the postoperative period

  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.

  7 days

Study Arms (1)

Adults undergoing abdominal surgery with laparotomy

OTHER

Respiratory variability before and after abdominal surgery

Other: Respiratory variability before and after surgery

Interventions

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.

Adults undergoing abdominal surgery with laparotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant,breast feeding women,
• minor,
• intubated patients or with criteria of imminent intubation
• subject unable to give his free and informed consent

Sponsors & Collaborators

• University Hospital Center of Martinique: lead

Study Sites (1)

CHU Martinique

Fort-de-France, 97261, Martinique

Location

MeSH Terms

Interventions

Postoperative Period

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• BEN HASSEN Kais, MD

  CHU de Martinique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: October 27, 2020
• Study Start: May 21, 2019
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: January 27, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)