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Clinical Trials/NCT04712084
NCT04712084CompletedNot Applicable

Postoperative Atelectasis Prevention by Application of PEEP and Pressure Support Ventilation: a Prospective Randomized Controlled Trial

Lennart Magnusson0 sites34 target enrollmentStarted: July 3, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
34
Primary Endpoint
Atelectatic surface

Study Overview

Brief Summary

General anaesthesia is known to promote lung collapse (atelectasis) which will persist in the postoperative period. Inflating the lung to a pressure of 40 cmH2O, called a vital capacity manoeuvre (VCM), performed a few minutes before extubation followed by the use of 40% of O2 will prevent postoperative atelectasis formation. This is not the case if VCM is followed by application of 100% of O2. However the use of 100% of O2 before tracheal extubation is still recommended for safety reason. Application of PEEP associated with pressure controlled ventilation before intubation prevents atelectasis formation despite the use of 100% of O2. The goal of our study was to show that performing a VCM 15 minutes before arousal followed by application of PEEP and pressure support ventilation (PSV) before and after tracheal extubation will prevent the recurrence of atelectasis despite the use of 100% of O2.

Materials and Methods With the ethic committee for research on human beings approval, the investigators randomly assigned 16 non-obese patients scheduled for a gynaecological laparoscopic surgery in two groups. At the end of the surgery the investigators performed a VCM (40cmH2O applied for 12 seconds), then O2 was increased to 100% in both groups. In the patients of the study group, a PEEP of 6 cmH2O was applied associated with a PSV of 8 cmH2O. This was continued after the extubation for 3 minutes. The O2 was then decreased to 40% and, when the expired oxygen saturation was < 50%, PEEP and PSV were removed. For the patients in the control group, no positive pressure was applied during spontaneous ventilation (PEEP = 0 and no PSV). The atelectasis were then measured by computed tomographic scanning.

Detailed Description

This is a prospective double-blinded study with prior informed written consent obtained from all patients.

Study Population Patients aged 18 to 65 years, American Society of Anesthesiologist (ASA) physical status classification I to III, undergoing gynaecological laparoscopic surgery under general anaesthesia were included in this prospective, randomised, double-blinded study.

Exclusion criteria were severe pulmonary disease, body mass index (BMI) more than 30 kg /m2 or less than 17, pregnancy or any other disease for which hypoxemia could be harmful. If the delay between extubation and the computed tomography (CT) scan was over 20 minutes, patients were also excluded.

Study treatments No premedication was given. General anaesthesia was standardized for all patients. Standard monitoring was applied. General anaesthesia was induced intravenously with fentanyl 1 to 2 μg/kg, propofol 2 to 3 mg/kg, and rocuronium 0.6 mg/kg. The airways were secured by endotracheal intubation.

Desflurane was used for maintenance at 1 minimal alveolar concentration (MAC) in 40% oxygen and air. Additional rocuronium was injected in order to maintain a train-of-four ratio (TOF ratio) between 0 and 1/4. Supplemental fentanyl was administered in order to maintain blood pressure and/or heart rate values within a range of 20% compared to baseline values.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Patient during general anesthesia are not aware of the technique applied. The radiologist calculating the surface of atelectasis is not aware of the technique applied

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •patient undergoing gynaecological laparoscopic surgery under general anesthesia

Exclusion Criteria

  • •BMI > 30 kg/m2 or < 17 kg/m2
  • •pregnancy; hypoxemic disease
  • •Delay between extubation and CT-scan > 20 minutes

Arms & Interventions

Control group

No Intervention

Extubation procedure following standard of care

Pressure support group

Experimental

Extubation procedure is performed with 100% of O2 but with application of positive pressure before and after extubation

Intervention: Positive pressure (Procedure)

Outcomes

Primary Outcomes

Atelectatic surface

Time Frame: 10 - 20 minutes after extubation

Whole lung CT scan with a special low doses protocol was obtained at end-expiratory position (at functional residual capacity)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Lennart Magnusson

MD Lennart Magnusson PhD, PD

Hôpital Fribourgeois

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