Trial Outcomes & Findings for Prophylactic Noninvasive Ventilation in vs Postoperative Standard Care in High Risk Patients According to ARISCAT Score (NCT NCT03629431)

Last Updated: 2026-01-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

266 participants

Primary outcome timeframe

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

Results posted on

2026-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	Postoperative Standard Care Standard care after surgery in postoperative unit postoperative standard care: Standard care received postoperatively	Prophylactic Non-invasive Ventilation Prophylactic noninvasive ventilation in postoperative and intensive care unit Prophylactic non-invasive ventilation: 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.
Overall Study NOT COMPLETED	5	8
Overall Study STARTED	133	133
Overall Study COMPLETED	128	125

Reasons for withdrawal

Reasons for withdrawal
Measure	Postoperative Standard Care Standard care after surgery in postoperative unit postoperative standard care: Standard care received postoperatively	Prophylactic Non-invasive Ventilation Prophylactic noninvasive ventilation in postoperative and intensive care unit Prophylactic non-invasive ventilation: 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.
Overall Study Withdrawal by Subject	5	8

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Postoperative Standard Care n=128 Participants Standard care after surgery in postoperative unit postoperative standard care: Standard care received postoperatively	Prophylactic Non-invasive Ventilation n=125 Participants Prophylactic noninvasive ventilation in postoperative and intensive care unit Prophylactic non-invasive ventilation: 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.	Total n=253 Participants Total of all reporting groups
Age, Continuous	66.8 years STANDARD_DEVIATION 11.3 • n=128 Participants	68.10 years STANDARD_DEVIATION 9.6 • n=125 Participants	67.4 years STANDARD_DEVIATION 10.5 • n=253 Participants
Sex: Female, Male Female	23 Participants n=128 Participants	27 Participants n=125 Participants	50 Participants n=253 Participants
Sex: Female, Male Male	105 Participants n=128 Participants	98 Participants n=125 Participants	203 Participants n=253 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Postoperative Standard Care n=128 Participants Standard care after surgery in postoperative unit postoperative standard care: Standard care received postoperatively	Prophylactic Non-invasive Ventilation n=125 Participants Prophylactic noninvasive ventilation in postoperative and intensive care unit Prophylactic non-invasive ventilation: 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.
Number of Participants With Acute Respiratory Failure Within the First 7 Days Following Surgery (or Until Hospital Discharge if Occurring First)	35 Participants	30 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Postoperative Standard Care n=128 Participants Standard care after surgery in postoperative unit postoperative standard care: Standard care received postoperatively	Prophylactic Non-invasive Ventilation n=125 Participants Prophylactic noninvasive ventilation in postoperative and intensive care unit Prophylactic non-invasive ventilation: 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.
Number of Participants With Healthcare-Associated Infections Within 30 Days After Surgery (Defined According to CDC Criteria) Pulmonary edema	15 Participants	11 Participants
Number of Participants With Healthcare-Associated Infections Within 30 Days After Surgery (Defined According to CDC Criteria) Pneumothorax	4 Participants	6 Participants
Number of Participants With Healthcare-Associated Infections Within 30 Days After Surgery (Defined According to CDC Criteria) Aspiration pneumonitis	1 Participants	2 Participants
Number of Participants With Healthcare-Associated Infections Within 30 Days After Surgery (Defined According to CDC Criteria) Respiratory infection	3 Participants	3 Participants
Number of Participants With Healthcare-Associated Infections Within 30 Days After Surgery (Defined According to CDC Criteria) Pleural effusion	41 Participants	36 Participants
Number of Participants With Healthcare-Associated Infections Within 30 Days After Surgery (Defined According to CDC Criteria) Bronchospasm	0 Participants	3 Participants
Number of Participants With Healthcare-Associated Infections Within 30 Days After Surgery (Defined According to CDC Criteria) Atelectasis	73 Participants	61 Participants
Number of Participants With Healthcare-Associated Infections Within 30 Days After Surgery (Defined According to CDC Criteria) Upper airways obstruction	10 Participants	4 Participants

SECONDARY outcome

Timeframe: 7 days

Number of patients reintubated

Outcome measures

Outcome measures
Measure	Postoperative Standard Care n=128 Participants Standard care after surgery in postoperative unit postoperative standard care: Standard care received postoperatively	Prophylactic Non-invasive Ventilation n=125 Participants Prophylactic noninvasive ventilation in postoperative and intensive care unit Prophylactic non-invasive ventilation: 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.
Reintubation Rate Within 7 Days	8 Participants	9 Participants

Adverse Events

Postoperative Standard Care

Serious events: 19 serious events

Other events: 128 other events

Deaths: 2 deaths

Prophylactic Non-invasive Ventilation

Serious events: 15 serious events

Other events: 125 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Postoperative Standard Care n=128 participants at risk Standard care after surgery in postoperative unit postoperative standard care: Standard care received postoperatively	Prophylactic Non-invasive Ventilation n=125 participants at risk Prophylactic noninvasive ventilation in postoperative and intensive care unit Prophylactic non-invasive ventilation: 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.
General disorders chirurgical complication	13.3% 17/128 • Number of events 17 • From signature of consent to the end of follow up (30 days)	5.6% 7/125 • Number of events 7 • From signature of consent to the end of follow up (30 days)
Cardiac disorders Cardiovascular disorders	47.7% 61/128 • Number of events 74 • From signature of consent to the end of follow up (30 days)	52.8% 66/125 • Number of events 67 • From signature of consent to the end of follow up (30 days)
General disorders Multiple organ failure	34.4% 44/128 • Number of events 52 • From signature of consent to the end of follow up (30 days)	24.8% 31/125 • Number of events 37 • From signature of consent to the end of follow up (30 days)
Gastrointestinal disorders Digestive disorders	35.9% 46/128 • Number of events 55 • From signature of consent to the end of follow up (30 days)	41.6% 52/125 • Number of events 58 • From signature of consent to the end of follow up (30 days)
Psychiatric disorders psycahtric disorders	18.0% 23/128 • Number of events 26 • From signature of consent to the end of follow up (30 days)	20.0% 25/125 • Number of events 28 • From signature of consent to the end of follow up (30 days)
Infections and infestations Infection	38.3% 49/128 • Number of events 55 • From signature of consent to the end of follow up (30 days)	26.4% 33/125 • Number of events 37 • From signature of consent to the end of follow up (30 days)
General disorders Complications of non-invasive ventilation	24.2% 31/128 • Number of events 33 • From signature of consent to the end of follow up (30 days)	43.2% 54/125 • Number of events 69 • From signature of consent to the end of follow up (30 days)
Respiratory, thoracic and mediastinal disorders Postoperative Pulmonary Complication	68.0% 87/128 • Number of events 147 • From signature of consent to the end of follow up (30 days)	63.2% 79/125 • Number of events 126 • From signature of consent to the end of follow up (30 days)

Additional Information

Dr Denis DUPOIRON

INSTITUT DE CANCEROLOGIE DE L'OUEST

Phone: 241352700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Postoperative Standard Care n=128 participants at risk Standard care after surgery in postoperative unit postoperative standard care: Standard care received postoperatively	Prophylactic Non-invasive Ventilation n=125 participants at risk Prophylactic noninvasive ventilation in postoperative and intensive care unit Prophylactic non-invasive ventilation: 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.
Blood and lymphatic system disorders Bleeding	1.6% 2/128 • Number of events 2 • From signature of consent to the end of follow up (30 days)	2.4% 3/125 • Number of events 3 • From signature of consent to the end of follow up (30 days)
General disorders Multiple organ failure	0.78% 1/128 • Number of events 1 • From signature of consent to the end of follow up (30 days)	0.80% 1/125 • Number of events 1 • From signature of consent to the end of follow up (30 days)
Gastrointestinal disorders Bowel obstruction	0.78% 1/128 • Number of events 1 • From signature of consent to the end of follow up (30 days)	0.00% 0/125 • From signature of consent to the end of follow up (30 days)
Renal and urinary disorders Acute Renal Failure	1.6% 2/128 • Number of events 2 • From signature of consent to the end of follow up (30 days)	1.6% 2/125 • Number of events 2 • From signature of consent to the end of follow up (30 days)
Nervous system disorders Transient ischemic attack	0.78% 1/128 • Number of events 1 • From signature of consent to the end of follow up (30 days)	0.00% 0/125 • From signature of consent to the end of follow up (30 days)
Cardiac disorders Cardiac arrest	0.78% 1/128 • Number of events 1 • From signature of consent to the end of follow up (30 days)	0.80% 1/125 • Number of events 1 • From signature of consent to the end of follow up (30 days)
Nervous system disorders Stroke	0.78% 1/128 • Number of events 1 • From signature of consent to the end of follow up (30 days)	0.80% 1/125 • Number of events 1 • From signature of consent to the end of follow up (30 days)
Respiratory, thoracic and mediastinal disorders cardiogenic shock	0.78% 1/128 • Number of events 1 • From signature of consent to the end of follow up (30 days)	0.00% 0/125 • From signature of consent to the end of follow up (30 days)
Hepatobiliary disorders cholecystisis	0.00% 0/128 • From signature of consent to the end of follow up (30 days)	0.80% 1/125 • Number of events 1 • From signature of consent to the end of follow up (30 days)
Psychiatric disorders Convulsive seizure	0.00% 0/128 • From signature of consent to the end of follow up (30 days)	0.80% 1/125 • Number of events 1 • From signature of consent to the end of follow up (30 days)
Blood and lymphatic system disorders Hemodynamic failure	1.6% 2/128 • Number of events 2 • From signature of consent to the end of follow up (30 days)	0.80% 1/125 • Number of events 1 • From signature of consent to the end of follow up (30 days)
Cardiac disorders Cardiac rythm disorders	0.78% 1/128 • Number of events 1 • From signature of consent to the end of follow up (30 days)	0.00% 0/125 • From signature of consent to the end of follow up (30 days)
Respiratory, thoracic and mediastinal disorders bronchail congestion	0.78% 1/128 • Number of events 1 • From signature of consent to the end of follow up (30 days)	0.00% 0/125 • From signature of consent to the end of follow up (30 days)
Blood and lymphatic system disorders Pericardial effusion	0.78% 1/128 • Number of events 1 • From signature of consent to the end of follow up (30 days)	0.00% 0/125 • From signature of consent to the end of follow up (30 days)
Gastrointestinal disorders Ileus	0.00% 0/128 • From signature of consent to the end of follow up (30 days)	1.6% 2/125 • Number of events 2 • From signature of consent to the end of follow up (30 days)
Respiratory, thoracic and mediastinal disorders Inhalation	0.00% 0/128 • From signature of consent to the end of follow up (30 days)	0.80% 1/125 • Number of events 1 • From signature of consent to the end of follow up (30 days)
Cardiac disorders Cardiac failure	0.78% 1/128 • Number of events 1 • From signature of consent to the end of follow up (30 days)	0.00% 0/125 • From signature of consent to the end of follow up (30 days)
General disorders food intolerance	0.78% 1/128 • Number of events 1 • From signature of consent to the end of follow up (30 days)	0.00% 0/125 • From signature of consent to the end of follow up (30 days)
Respiratory, thoracic and mediastinal disorders mediastinitis	1.6% 2/128 • Number of events 2 • From signature of consent to the end of follow up (30 days)	0.00% 0/125 • From signature of consent to the end of follow up (30 days)
Respiratory, thoracic and mediastinal disorders pneumopathy	0.00% 0/128 • From signature of consent to the end of follow up (30 days)	0.80% 1/125 • Number of events 1 • From signature of consent to the end of follow up (30 days)