Comparison of Hemodynamic Effect of 2 Methods for Alveolar Recruitment Maneuver in Anesthetized Patients

NCT03215329 | Unknown

• 1 other identifier: A15-D27-VOL.25
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

During general anaesthesia, pulmonary atelectasis has been shown to occur in 85 to 90% of patient. Pulmonary atelectasis increases occurrence of postoperative pulmonary complication including pneumoniae. Pulmonary atelectasis can be prevented or reversed by alveolar recruitment manoeuvres (ARM). Two methods for ARMs have been described. A sustained continuous positive airway pressure (CPAP) or a stepwise increase in PEEP.The transient increase in intrathoracic pressure during ARMs decreases venous return and increases pulmonary vascular resistance. This result in a decrease in right and left ventricular stroke volume (SV). Finally, the deleterious hemodynamic effects of ARMs may be exacerbated by hypovolemia, heart failure, and in patients with chronic treatment wich impedes cardiovascular responses to hypovolemia. At our best knowledge, there is no study which compared the hemodynamic effects of ARM using sustained CPAP or stepwise increase in PEEP. Consequently, the present study was designed to examine the hemodynamic effects of 2 ARM methods in anesthetized patients.

Conditions

Stroke Volume Variation; Arterial Pressure

Outcome Measures

Primary Outcomes (1)

• change in stroke volume

  stroke volume measured by transoesophageal doppler probe

  before and during the alveolar recruitment maneuver

Secondary Outcomes (6)

• cardiac index

  before, during, 1 and 3 min after the alveolar recruitment maneuver

• pulse pressure variation

  before, during, 1 and 3 min after the alveolar recruitment maneuver

• arterial pressure

  before, during, 1 and 3 min after the alveolar recruitment maneuver

• heart rate

  before, during, 1 and 3 min after the alveolar recruitment maneuver

• peak velocity

  before, during, 1 and 3 min after the alveolar recruitment maneuver

Study Arms (2)

CPAP30

Alveolar recruitment maneuver with a continuous positive airway pressure (CPAP) at 30 cmH2O during 30 seconds

Procedure: abdominal or vascular surgery

PEEPsteps

Alveolar recruitment maneuver with a stepwise increase and decrease in positive end expiratory pressure from 5 to 20 cmH2O.

Procedure: abdominal or vascular surgery

Interventions

abdominal or vascular surgery PROCEDURE

Intermediate or high risk abdominal or vascular surgery

CPAP30; PEEPsteps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

adult patients aged 18 year and above, American Society of Anesthesiologists physical status II to IV, scheduled for intermediate and high risk abdominal and vascular surgery (as defined by the guidelines on non-cardiac surgery: cardiovascular assessment and management), and equipped with a radial arterial catheter and transoesophageal doppler monitor

You may qualify if:

• adult patients aged 18 year and above, American Society of Anesthesiologists physical status II to IV, scheduled for intermediate and high risk abdominal and vascular surgery (as defined by the guidelines on non-cardiac surgery: cardiovascular assessment and management), and equipped with a radial arterial catheter and transoesophageal doppler monitor

You may not qualify if:

• Patients less than 18 year-old, adults under protection, pregnant women, patients with atrial fibrillation, history of right ventricular dysfunction, known left ventricular ejection fraction \< 30%, or preoperative pulmonary disease

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU de Caen

Caen, 14000, France

RECRUITING

MeSH Terms

Interventions

Vascular Surgical Procedures

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jean-Luc Hanouz, M.D,Ph.D

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Luc Hanouz, M.D,Ph.D

CONTACT

hanouz-jl@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 12, 2017
• Study Start: January 2, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: July 12, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)