Influence of Tidal Volume on Postoperative Pulmonary Function

NCT00795964 | Completed

• 1 other identifier: Intraoperative tidalvolume-25
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Lung function impairment is common after abdominal surgery. Few preventive strategies exist against postoperative lung function impairment. A new potential preventive strategy against postoperative lung function impairment comes from research on critically ill patients with severe respiratory failure. In this field research has long focused on influence of breathing volume (= tidal volume) during mechanical ventilation on outcome. It has been shown, that low tidal volumes improve patients outcomes as compared to (conventional) high tidal volumes. Therefore, we propose a patient and investigator blinded randomised trial to test the hypotheses that intraoperative mechanical ventilation with low tidal volumes as compared to high tidal volumes reduces postoperative lung function impairment in high risk patients.

Conditions

Pulmonary Function

Keywords

tidal volume; predicted body weight; lung function; respiratory outcome; Respiratory Function Tests; surgery

Outcome Measures

Primary Outcomes (1)

• Lung function as assessed by spirometry

  1 year

Secondary Outcomes (5)

• lung function as assessed by blood gas analysis

  1 year

• time till hospital discharge

  1 year

• postoperative organ dysfunction

  1 year

• postoperative chest x-rays

  1 year

• time till mobilisation

  1 year

Study Arms (2)

1

EXPERIMENTAL

intraoperative mechanical ventilation with 6 ml/kg predicted body weight

Other: Randomized application of intraoperative tidal volume

2

ACTIVE COMPARATOR

intraoperative mechanical ventilation with 12 ml/kg predicted body weight

Other: Randomized application of intraoperative tidal volume

Interventions

Randomized application of intraoperative tidal volume OTHER

intraoperative mechanical ventilation with 6 ml/kg predicted body weight

Also known as: Respiratory management

1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent
• age ≥ 50 years and ASA classification ≥ II
• elective upper abdominal surgery of at least 3 hours duration
• general anaesthesia plus epidural anaesthesia.

You may not qualify if:

• \< 18 years of age
• impaired mental state
• unwillingness to participate
• pregnancy
• duration of surgery \< 3 hours
• ASA physical status ≥ IV
• increased intracranial pressure
• neuromuscular disease that impairs spontaneous breathing

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Department of Anesthesiology

Düsseldorf, 40225, Germany

Location

Study Officials

• Tanja A Meyer-Treschan, MD

  Department of Anesthesiology at Duesseldorf University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 21, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 24, 2010

Record last verified: 2010-09

Locations

DE (1)