Impact of Blades Used for Scheduled Orotracheal Intubation on Postoperative Sore Throat

NCT01118533 | Completed DMC

• 1 other identifier: K080902
• Study Type: interventional
• Target: 712
• Locations: 1 country
• Sites: 1

Brief Summary

Orotracheal intubation following general anesthesia requires blades to be performed. The risk of patients contamination with infectious agents related to reusable metal blades leads to promote single-use blades. Some of these latter are plastic and this material may need more strength to lift the jaw and expose the larynx before orotracheal intubation. Sometimes, change of blade, from plastic to metal, during the procedure is necessary to increase the larynx exposure. This change of blade may increase the frequency of sore throat following orotracheal intubation. Consequently, the study hypothesis is an increase of both sore throat intensity and frequency with the plastic blades compared with the metal blades. The primary purpose of the present study is to compare the impact of these two types of blades, metal versus plastic, on sore throat intensity and frequency following scheduled orotracheal intubation for general anesthesia

Conditions

Tracheal Intubation Morbidity; Sore Throat

Keywords

Intubation; Sore throat; Blades; Laryngoscopy; Morbidity

Outcome Measures

Primary Outcomes (1)

• The frequency of patients presenting a post-operative sore throat whose intensity is above 4 on a visual analogue scale (VAS) graded from 0 (no pain) to 10 (unbearable pain) collected at the discharge of the post-anesthesia care unit (PACU).

  Two years

Secondary Outcomes (12)

• The frequency of patients presenting a post-operative sore throat whose intensity is different from 0/10 without swallowing

  2 years

• The pain intensity will be measured at the discharge of the post-anesthesia care unit (PACU) with a slide ruler displaying a visual analogue scale graded from 0 (no pain) to 10 (unbearable pain) on the blinded face

  seven days

• the degree of voice modification on a VAS

  Seven days

• the sore throat VAS during swallowing.

  seven days

• jaw pain

  seven days

Study Arms (2)

metallic blades

EXPERIMENTAL

laryngoscope blade material

Device: metal reusable blades MacIntosh

plastic laryngoscope blades

ACTIVE COMPARATOR

Laryngoscope Blade Material

Device: Single use plastic blades HEINE XP®

Interventions

metal reusable blades MacIntosh DEVICE

laryngoscope blades

metallic blades

Single use plastic blades HEINE XP® DEVICE

laryngoscope blades

Also known as: Sign use plastic blades HEINE XP®

plastic laryngoscope blades

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient, 18-70 years-old scheduled for surgery planned under general anesthesia with orotracheal intubation
• Patient who has carefully read the information notice and is not opposed to participate to the study
• Patient having a assurance policy or a similar regimen

You may not qualify if:

• Pregnancy
• Difficulty to understand the current language (French)
• Presence of predictive factors of difficult orotracheal intubation
• Previous difficult tracheal intubation Grade IV of the MALLANPETI score Limited mouth opening (inter-incisive distance \< 3.5 cm) Limited cervical mobility Thyromental distance \< 6 cm History of radiotherapy or surgery for ENT cancer Retrognathism Presence of gastric tube for postoperative purposes Presence of Pharyngeal and Laryngeal signs before surgery
• Type of surgery Surgery performed without orotracheal intubation Thyroid surgery ENT surgery Withdrawal of gastric banding Bariatric surgery Ambulatory surgery (one-day surgery)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

hospital Center of Meaux, department of anesthesiology

Meaux, Meaux, 77104, France

Location

Related Publications (2)

• Amour J, Marmion F, Birenbaum A, Nicolas-Robin A, Coriat P, Riou B, Langeron O. Comparison of plastic single-use and metal reusable laryngoscope blades for orotracheal intubation during rapid sequence induction of anesthesia. Anesthesiology. 2006 Jan;104(1):60-4. doi: 10.1097/00000542-200601000-00011.

  PMID: 16394691 BACKGROUND

• Maktabi MA, Smith RB, Todd MM. Is routine endotracheal intubation as safe as we think or wish? Anesthesiology. 2003 Aug;99(2):247-8. doi: 10.1097/00000542-200308000-00002. No abstract available.

  PMID: 12883393 BACKGROUND

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Serge Ndoko, MD

  Hospital Center of Meaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: May 6, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 10, 2016

Record last verified: 2016-05

Locations

FR (1)