Cuffed Versus Uncuffed Tracheal Tubes in Neonates Undergoing Elective Surgery

NCT05296668 | Completed

• 1 other identifier: MD-62-2021
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This thesis aims to assess the safety and efficacy of usage of cuffed ETT in neonate undergoing elective surgeries.

Conditions

Anesthesia, Endotracheal; Neonate

Keywords

Cuffed endotracheal tube; Neonates; General anesthesia

Outcome Measures

Primary Outcomes (1)

• The incidence of ETT exchange to find the appropriate ETT

  the incidence of ETT exchange to find the appropriate ETT defined as:(the absence of resistance to insertion of the tube and the presence of audible leak with inflation pressures of 20 cmH2O).

  2 hours

Secondary Outcomes (6)

• Duration of intubation

  10 minutes

• Leakage around the ETT

  2 hours

• Number of attempts to insert and correctly size the tracheal tube.

  10 minutes

• Desaturation incidence

  30 minutes postoperative

• Hoarseness of voice.

  30 minutes postoperative

Study Arms (2)

Cuffed ETT group

EXPERIMENTAL

(group C) to receive a cuffed ETT for airway management.

Device: Cuffed ETT (Microcuff®, Halyard Health Inc., Atlanta, GA, USA); Device: Uncuffed ETT group

Uncuffed ETT group

ACTIVE COMPARATOR

(group U) to receive an uncuffed ETT for airway management.

Device: Cuffed ETT (Microcuff®, Halyard Health Inc., Atlanta, GA, USA); Device: Uncuffed ETT group

Interventions

Cuffed ETT (Microcuff®, Halyard Health Inc., Atlanta, GA, USA) DEVICE

(group C) to receive a cuffed ETT for airway management.

Cuffed ETT group; Uncuffed ETT group

Uncuffed ETT group DEVICE

(group U) to receive an uncuffed ETT for airway management.

Also known as: Uncuffed ETT (Mallinckrodt® Contour Murphy Eye)

Cuffed ETT group; Uncuffed ETT group

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates (infant in the first 28 days after birth)
• Full term (more than 37 gestational weeks)
• More than 3 kg bodyweight
• ASA I-II
• Scheduled for elective surgeries under general anesthesia requiring endotracheal intubation.

You may not qualify if:

• Parents or legally authorized personnel refusal.
• Anatomical abnormalities of upper air way.
• Emergency surgery.
• Low birth weight less than 3 kg
• Surgery longer than 2 hours
• Premature neonates
• Upper airway surgery
• Requirement for postoperative ventilation

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasralainy

Cairo, Egypt

Location

Related Publications (1)

• Sarhan K, Walaa R, Hasanin A, Elgohary M, Alkonaiesy R, Nawwar K, Elsonbaty M, Elsonbaty A. Cuffed versus uncuffed endotracheal tubes in neonates undergoing noncardiac surgeries: A randomized controlled trial. Paediatr Anaesth. 2024 Oct;34(10):1045-1052. doi: 10.1111/pan.14953. Epub 2024 Jun 22.

  PMID: 38922733 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Induction of anesthesia will be performed by the attending senior anesthesia resident who has finished at least 2 years of residency (who is independent of the study team). All intraoperative measurements will be collected by an anesthetist who was not involved in the induction of anesthesia. All postoperative measurements will be collected by PACU nurse who is independent of the study team
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Model Details: Recruited neonates will be randomly assigned to one of two groups in a 1:1 ratio; (group C) to receive a cuffed ETT and (group U) to receive an uncuffed ETT for airway management.

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 25, 2022
• Study Start: March 1, 2022
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)