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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01118533
First received: March 29, 2010
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention
Tracheal Intubation Morbidity
Sore Throat
Device: metal reusable blades MacIntosh
Device: Single use plastic blades HEINE XP®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: A Prospective, Multicenter, Randomized and Single Bind Trial. Influence of Laryngoscope Blade Material on Postoperative PHARYNGEAL AND LARYNGEAL Morbidity Following Scheduled OroTracheal Intubation

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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). [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The frequency of patients presenting a post-operative sore throat whose intensity is different from 0/10 without swallowing [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: seven days ] [ Designated as safety issue: Yes ]
    The pain will be evaluated everyday during two days. If the pain persists, it will be evaluated everyday till the pain disappears or till the end of the patient participation (seven days).

  • the degree of voice modification on a VAS [ Time Frame: Seven days ] [ Designated as safety issue: Yes ]
    dysphonia

  • the sore throat VAS during swallowing. [ Time Frame: seven days ] [ Designated as safety issue: Yes ]
    dysphagia

  • jaw pain [ Time Frame: seven days ] [ Designated as safety issue: Yes ]
  • lips injuries [ Time Frame: seven days ] [ Designated as safety issue: Yes ]
  • dental injuries [ Time Frame: seven days ] [ Designated as safety issue: Yes ]
  • blood on the blade [ Time Frame: seven days ] [ Designated as safety issue: Yes ]
  • the intubation difficulty score (IDS) [ Time Frame: one day ] [ Designated as safety issue: Yes ]
  • the frequency of difficult intubation [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
  • the frequency of change of blade during the tracheal intubation procedure [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • the tracheal intubation duration. [ Time Frame: one day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 712
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: metallic blades
laryngoscope blade material
Device: metal reusable blades MacIntosh
laryngoscope blades
Other Name: metal reusable blades MacIntosh
Active Comparator: plastic laryngoscope blades
Laryngoscope Blade Material
Device: Single use plastic blades HEINE XP®
laryngoscope blades
Other Name: Sign use plastic blades HEINE XP®

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patient, 18-70 years-old scheduled for surgery planned under general anesthesia with orotracheal intubation
  • Patient who has underwent a clinical examination before inclusion
  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118533

Contacts
Contact: Serge Ndoko, MD 33 (1) 64 35 39 69 s-ndoko@ch-meaux.fr

Locations
France
hospital Center of Meaux, department of anesthesiology Recruiting
Meaux, France, 77104
Contact: Serge Ndoko, MD    33 (1) 64 35 39 69    s-ndoko@ch-meaux.fr   
Principal Investigator: Serge Ndoko         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Serge Ndoko, MD Hospital Center of Meaux
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01118533     History of Changes
Other Study ID Numbers: K080902
Study First Received: March 29, 2010
Last Updated: February 20, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Intubation
Sore throat
Blades
Laryngoscopy
Morbidity

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014