Postoperative Lung Collapse Prevention

NCT04712084 | Completed

• 1 other identifier: anesth2020
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atelectasis

Keywords

anesthesia, general

Outcome Measures

Primary Outcomes (1)

• Atelectatic surface

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

  10 - 20 minutes after extubation

Study Arms (2)

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

Procedure: Positive pressure

Interventions

Positive pressure PROCEDURE

Inspiratory support of 8 cmH2O was applied associated with PEEP at 6 cmH2O. After extubation, same support was applied by facemask for 3 minutes

Pressure support group

Eligibility Criteria

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

You may qualify if:

• patient undergoing gynaecological laparoscopic surgery under general anesthesia

You may not qualify if:

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

Sponsors & Collaborators

• Lennart Magnusson: lead

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lennart Magnusson

  Hopital cantonal Fribourg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD Lennart Magnusson PhD, PD

Model Details: prospective double-blinded study Randomization was performed when spontaneous ventilation resumed at the end of the surgery

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: July 3, 2013
• Primary Completion: July 22, 2014
• Study Completion: July 22, 2014
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share