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OpenTrials
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NCT Number: NCT03629431

Prophylactic Noninvasive Ventilation in vs Postoperative Standard Care in High Risk Patients According to ARISCAT Score

Postoperative pulmonary complications are one of the most common complications after surgery.

Noninvasive ventilation has been proposed post-operatively to prevent postoperative pulmonary complications.

Prophylactic noninvasive ventilation performed systematically in a non-specific population is without interest.

The difficulty for the practitioner is to target patients at higher risk of developing a postoperative pulmonary complications in order to guiding them to a post-operative specialized care pathway.

The use of the ARISCAT score, validated on a large European prospective cohort, makes it possible to evaluate, preoperatively, the risk of occurrence of postoperative pulmonary complication in the patient.

The hypothesis of the present research is that early postoperative preventive treatment with noninvasive ventilation, in patients at risk of postoperative pulmonary complications according to the preoperative evaluation according to the ARISCAT score, could have an interest in reducing these complications with a superior efficiency over standard techniques.

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Key information

Conditions

Surgical Patients Pulmonary Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu D'Angers, Angers, France

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About this study

After verification of eligibility criteria and ARISCAT score, patients at high risk of COPD are randomized in the study.

At the exit of the operating room, patients are referred to the services according to their randomization arm :

  • arm with prophylactic noninvasive ventilation in intensive care unit. Patients will receive noninvasive ventilation for a maximum of 48 hours. Sessions last 1 hour and are repeated every 2 to 3 hours
  • arm with standard care in conventional care unit. Patients receive standard care such as physiotherapy.

In both arms, patient follow-up is 7 days maximum.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient 18 years of age or older
  • Patient scheduled for surgery or considered semi-urgent (=pre-anesthesia consultation <48h before the surgical procedure) under General Anesthesia or under Loco-Regional Anesthesia
  • Patient with an ARISCAT score higher than or equal to 45 - Obtaining the signed written consent of the patient
  • Patient affiliated to a social security scheme

Exclusion criteria

  • Minor patients, pregnant or lactating women
  • Obstetrical interventions
  • Surgery under Local Anesthesia or Peripheral Nerve,
  • Interventions taking place outside an interventional room
  • Interventions for previous surgical complications
  • Second surgery during study
  • Organ transplantation
  • Patients already intubated in preoperative
  • Outpatient surgery
  • Refusal of participation or inability to issue informed consent
  • Person deprived of liberty or adult under guardianship
  • Participation in another interventional study

Treatment and study plan

Prophylactic non-invasive ventilation

Procedure

The sessions of NIV last 1 hour and are repeated every 2 to 3 hours with a goal of a daily assistance period of 6 to 8 hours for a minimum of 24 hours.

The sessions are spaced by periods of unassisted ventilation of 2 hours allowing the patient to rest, feed, receive care including physiotherapy sessions.

postoperative standard care

Procedure

Standard care received postoperatively

Primary outcomes

  1. Number of Participants With Acute Respiratory Failure Within the First 7 Days Following Surgery (or Until Hospital Discharge if Occurring First)

    Time frame: Up to 7 days post-surgery or until hospital discharge (study duration: 23 months)

    The outcome was reported as the count of participants who experienced acute respiratory failure, defined as the need for invasive or non-invasive mechanical ventilation within 7 days after surgery or until hospital discharge, whichever occurred first. All events were validated by an adjudication committee in this randomized, single-blind trial.

Secondary outcomes

  1. Number of Participants With Healthcare-Associated Infections Within 30 Days After Surgery (Defined According to CDC Criteria)

    Time frame: 30days

    The outcome was reported as the count of participants who developed healthcare-associated infections within 30 days after surgery, defined according to the Centers for Disease Control and Prevention (CDC) criteria. All events were validated by an adjudication committee

  2. Reintubation Rate Within 7 Days

    Time frame: 7 days

    Number of patients reintubated

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Collaborators

  • Direction Générale de l'Offre de Soins

Registry information

Official study title

Multicenter, Randomized, Open Study, Assessing Prophylactic Noninvasive Ventilation in Intensive Care Unit vs Postoperative Standard Care for Patients With High Risk of Postoperative Pulmonary Complication With Preoperative ARISCAT Score

Acronym: ANTICIPUSC

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 14, 2018
Registry last updated
Jan 27, 2026

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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