Use of a Pressurized Face Mask for Preventing Respiratory Complications After Chest Surgery

Lung Resection Clinical Trial

Official title:

Phase 4, Randomized, Controlled Trial on the Efficacy as Prophylaxis of Postoperative Respiratory Complications and Safety of Continuous Positive Airways Pressure (CPAP) Applied Throughout Boussignac Mask During the Immediate Postoperative Period of Patients Undergoing Lung Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02771327
• Other study ID #: FIBHGM-ECNC010-2010
• Status: Completed
• Phase: Phase 4
• First received: April 4, 2016
• Last updated: November 17, 2016
• Start date: February 2014
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

Evaluation of efficacy and safety from 6hours of 7 cmH2O CPAP after weaning in patients undergoing lung resection, on the prevention of atelectasis / pneumonia and gas exchange improve.

Description:

Multicenter randomized clinical trial. 460 patients randomly assigned to treatment and control groups will be studied. The main variables are the frequency of atelectasis or pneumonia, defined by clinical and radiological criteria, the FiO2/PaO2 ratio, 7 and 24 h after weaning, and hospital stay.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Undergoing thoracic surgery including resection of lung parenchyma.

• To have given signed consent to enter in the study.

Exclusion Criteria:

Weaning in the first 4h after the intervention end.

• Suspected bronchopleural fistula at the admission to the surgical ICU.

• Patients with facial problems or a history of intolerance to CPAP masks.

• Having significant bullous emphysema defined as the presence of more than 5 contiguous bullae <2cm or the existence of a pulmonary bulla> 2 cm or dystrophy bullosa, not in the area to dry and having had a previous pneumothorax.

• Known Obstructive Apnea Hypopnea syndrome known or some form of noninvasive ventilation prescribed.

• Immunocompromised patients, or having used an immunosuppressor drug at least one month prior to surgery with potential (except corticosteroids administered by inhalation)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lung Resection

Intervention

Device:
• CPAP plus Gas

• ventimask plus gas

Locations

Country	Name	City	State
Spain	H. Ramón y Cajal	Madrid
Spain	HGU Gregorio Marañón	Madrid
Spain	Hopsital universitario La Princesa	Madrid
Spain	HU 12 de octubre	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of atelectasis- Pneumonia, and other postoperative complications,		1 week after the surgical intervention	No
Secondary	Gas exchange ( Pa/FiO2)		1 week after the surgical intervention	No
Secondary	Hospital stay comparison between arms		from the surgical intervention date to hospital discharge date up to 1month	No