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Updated: May 10, 2025

Author Spotlight: A Non-Intubated Video-Assisted Thoracoscopic Surgery with Multimodal Analgesia and Sevoflurane Inhalation Anesthesia

Author Spotlight: A Non-Intubated Video-Assisted Thoracoscopic Surgery with Multimodal Analgesia and Sevoflurane Inhalation Anesthesia

Published on: May 26, 2023

PErioperative respiratory care aNd outcomes for patients underGoing hIgh risk abdomiNal surgery (PENGUIN): a

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|April 21, 2025

Abstract

Background:

Infections are a common complication of abdominal surgery in low- and middle-income countries (LMICs). The role of a high fraction of inspired oxygen (FiO₂) and chlorhexidine mouthwash in preventing post-operative infections is unconfirmed.

Methods:

Internal pilot phase of an international outcome assessor-blinded, 2x2 factorial randomised trial of patients aged ≥10-years undergoing midline laparotomy in LMIC hospitals. The main trial objectives are to compare the clinical effectiveness of preoperative 0.2% chlorhexidine mouthwash in preventing pneumonia versus no mouthwash, and 80-100% perioperative FiO₂ to prevent surgical site infection (SSI) versus 21-35% FiO₂. This 12-month internal pilot assessed feasibility of hospital site opening, patient recruitment, intervention adherence, patient follow-up and safety. Patients were randomised in a 1:1:1:1 ratio to the four intervention group combinations and followed up for 30 days.

Results:

We recruited 927 patients from seven hospitals in India and South Africa over 12 months from November 2020. There were 907 adults (97.8%) and 20 children aged ten or over (2.2%): 89/927 (9.6%) patients died. Site opening reached 70% of our target (7/10) hospitals, and patient recruitment 107% (927/870). 917/927 (99%) patients in the mouthwash arm, and 840/927 (91%) patients in the oxygen arm received the allocated intervention. Lower adherence to the oxygen intervention related mainly to clinically necessary FiO₂ increases in the 21-35% FiO₂ arm. 30-day follow-up was completed appropriately for 924/927 (99%) patients. and was performed by a masked assessor for all patients. There were no reported safety events.

Conclusion:

This pilot showed the feasibility and safety of a major phase III trial in post-operative infection prevention in LMICs.

Trial Registration:

ClinicalTrials.gov NCT04256798.

Insights

This pilot study demonstrated the feasibility of a large trial investigating interventions to prevent post-operative infections in low- and middle-income countries (LMICs). High fraction of inspired oxygen (FiO2) and chlorhexidine mouthwash were tested for efficacy.

Area of Science:

Medical Research
Infectious Diseases
Surgical Complications

Background:

Post-operative infections are a significant challenge in low- and middle-income countries (LMICs).
The effectiveness of high fraction of inspired oxygen (FiO2) and chlorhexidine mouthwash in preventing these infections remains unconfirmed.

Purpose of the Study:

To assess the feasibility and safety of conducting a large-scale Phase III trial.
To evaluate the clinical effectiveness of preoperative 0.2% chlorhexidine mouthwash and perioperative high FiO2 in preventing post-operative infections in LMICs.

Main Methods:

An internal pilot phase of a 2x2 factorial randomized controlled trial involving patients aged 10 years or older undergoing midline laparotomy.
Interventions included 0.2% chlorhexidine mouthwash versus no mouthwash, and 80-100% FiO2 versus 21-35% FiO2.
Feasibility outcomes included hospital site activation, patient recruitment, intervention adherence, follow-up completion, and safety over 12 months.

Main Results:

Recruited 927 patients across seven hospitals in India and South Africa.
Achieved high adherence for mouthwash (99%) and oxygen (91%) interventions.
Demonstrated high rates of patient follow-up (99%) and no reported safety events.

Conclusions:

The pilot study successfully demonstrated the feasibility and safety of a major Phase III trial.
The findings support proceeding with the main trial to confirm the effectiveness of interventions for post-operative infection prevention in LMICs.

Read full analysis

Keywords:

Pilot trial abdominal surgery feasibility study global health perioperative care postoperative pneumonia surgical site infection

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