Effects of Intraoperative Continuous Airway Pressure (CPAP) on the Inflammatory Response to One-lung Ventilation

Effects of Intraoperative Continuous Airway Pressure (CPAP) on the Inflammatory Response of the Lung With Cancer Undergoing Lobectomy. A Randomised Placebo-controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01368601

Enrollment

Registered

2011-06-08

Start date

2011-05-31

Completion date

2020-10-31

Last updated

2019-03-28

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

Conditions

Lung Cancer

Keywords

Lung Cancer, CPAP, PPC, lobectomy, One-lung ventilation

Brief summary

This is a randomized placebo-controlled trial studying the effects of intraoperative continuous airway pressure (CPAP) on the inflammatory response of the lung with cancer undergoing lobectomy.

Detailed description

Pulmonary lobectomy induces an inflammatory response of this lung caused by intraoperative atelectasis and re-expansion. This inflammatory response can be attenuated with treatment, also decreasing postoperative pulmonary complications (PPC). Thus, avoiding complete atelectasis with partial insufflation of the lung during surgery could be useful to decrease inflammatory response and PPC.

Interventions

PROCEDURECPAP (Continuous airway pressure)

To evaluate if continuous positive airway pressure (CPAP) on the lung undergoing lobectomy can decrease the inflammatory response and PPC.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Adults (18-80 aged) with American Society of Anesthesiologists physical status I-III, scheduled to undergo elective thoracic surgery with lung resection performed through thoracotomy, and requiring OLV (one lung ventilation)during surgery.

Exclusion criteria

* Ongoing treatment with any dose of systemic or topical steroids, acute pulmonary or extrapulmonary infections (elevated C-reactive protein \[CRP\]), history of recurrent pneumothoraces, previous thoracic surgery.

Design outcomes

Primary

Measure	Time frame	Description
Alveolar and plasmatic cytokines measured before and after atelectasis and re-expansion.	From preoperative to postoperative (24h) period.	Alveolar and plasmatic cytokines measured before and after atelectasis and re-expansion.

Secondary

Measure	Time frame	Description
Alveolar MICA	From preoperative to postoperative period (24h)	Alveolar MICA I (major histocompatibility complex (MHC) class I chain related genes) expression measured at the same control times.
CT-Scan	22-24h after surgery	Postoperative distribution of well-aerated, non aerated or poorly aerated lung volumes.
Postoperative pulmonary complications (PPC).	Participants will be followed for the duration of hospital stay, an expected average of 10 days.	PPC.

Countries

Spain

Outcome results

None listed

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